Preserve Access to Affordable Generics Act

Mr. President, I suggest the absence of a quorum.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I suggest the absence of a quorum and ask unanimous consent that the time in the quorum call be charged to both sides equally.

Mr. President, let me yield myself 5 minutes from the time allotted.

Mr. President, the vote that will occur at 10:30 or thereabouts is a vote that will determine whether we can proceed to have a vote on my amendment. It is called a cloture vote--to shut off debate so we can move to the amendment I have offered. I wish to remind my colleagues again of what this amendment is.

This amendment is a bipartisan amendment sponsored by 33 Senators, Republicans and Democrats--Senator Grassley, who just spoke, myself, Senator Snowe, Senator McCain, Senator Kennedy, Senator Stabenow; a wide range of Senators, Republicans and Democrats--who believe U.S. citizens ought to be able to purchase FDA-approved prescription drugs, the identical FDA-approved drugs that are sold in other countries for a fraction of the cost of what they are sold for in this country. We believe the American people ought to be able to make the global economy work for them and ought to be able to access those same prescription drugs as long as they are in a chain of custody that makes them safe and as long as they are FDA approved.

I described them yesterday, and let me, again, ask unanimous consent to describe to my colleagues these two bottles.

In these bottles is the medication called Lipitor. Lipitor is made in Ireland. It is a common cholesterol-lowering drug taken by a good many Americans. As you can see, when made in the plant in Ireland, it is put in these bottles--identical bottles--with a label that is blue in this case, red in this case, otherwise identical. The difference in this situation is that this blue bottle is sent to Canada from Ireland, this red bottle is sent to the United States. It is the same pill, same bottle, made in the same manufacturing plant, FDA approved.

The difference? Well, the American consumer is told: You get to pay twice as much for the identical drug. You get to pay twice as much.

It describes a serious problem of what I believe is the overpricing of prescription drugs in this country. We pay the highest prices in the world for prescription drugs. I do not know of anyone in this Chamber who stands up and says: Let me sign up for that. Let me tell you, I think it is right, I think it is fair, and I think it is important that the American consumers pay the highest prices in the world for prescription drugs.

I do not think anybody stands up here and claims that. What they claim is, if they do not get that kind of money, they will shut down research and development, and they are forced to charge lower prices overseas because those governments overseas won't allow them to make money.

Let me show you what happened a while ago. This Chamber--without my support because it was a foolish thing to do--said: Do you know what. We want to say to the biggest economic interests in our country, the biggest companies that have moved American jobs overseas and make investments overseas, we want to say to them that if you make profits overseas, we will allow you to repatriate those profits into this country, back here, and you get to pay a special tax rate.

Normally, when a company repatriates its profits made elsewhere, it pays normal income tax rates. But this Congress said to them: Do you know what. We will give you a special deal, a big fat tax break. If you repatriate your foreign profits, you get to pay a 5.25-percent income tax rate. Nobody gets to pay a 5.25-percent income tax rate. I would love to pay that. Everybody else would, as well. But the biggest companies in our country got to repatriate a massive amount of money and save, I estimate, about $100 billion in taxes that should have been paid because they got a 5.25-percent sweetheart deal.

So let me just turn to one drug company--Pfizer, a good company, one of the world's biggest drugmakers. This is from the New York Times of June 24, 2005. It said it would return ``$8.6 billion in overseas profits.'' So the combined repatriation of $36.9 billion--it had already announced $28.3 billion--so that makes it $36 billion they are repatriating in profits they have made overseas. The New York Times says that is four times what Pfizer spent on research and development last year.

But isn't it interesting that they charge lower prices for prescription drugs in other countries, they say they do not make money in other countries, yet when they get a big fat sweetheart deal to pay a 5.25-percent income tax rate, they repatriate $36 billion. That is on the profit they made in other countries. It looks to me as if it is profitable selling these drugs at lower prices in foreign countries. So much for that argument.

The price discrepancy I have indicated previously. I used Canada as an example, but I could use France, Italy, Germany, Spain--it would not matter. Lipitor, 96 percent higher prices for Americans; Prevacid, 97 percent higher prices for Americans; Nexium, 55 percent higher prices; Zocor--the fact is, we are paying the highest prices for brand-name prescription drugs in the world, and it is unfair. We are trying to change that.

What we are saying is: Let's let the global economy work for everybody, not just the large pharmaceutical industry. How about allowing it to work for regular folks, to buy a safe FDA-approved prescription drug, for example, from a Canadian pharmacy.

Can anybody give me one reason why a U.S.-licensed pharmacist should not be able to go to a licensed pharmacist in Winnipeg, Canada--both licensed, both with an identical chain of custody--why a U.S.-licensed pharmacist should not be able to go to a licensed pharmacist in Canada and acquire an FDA-approved drug, such as Tamoxifen, at one-fourth or one-fifth of the price charged in the United States and pass the savings along to the consumer? I am not asking for five reasons. I am asking: Can anyone give me one reason why that should be prohibited? I think the answer is that there is not a good reason why we should prohibit that sort of thing.

So we will have a vote on this amendment. My hope is we will be able to invoke cloture so we will be able to proceed to the amendment. There will be a Cochran amendment to my amendment, a second degree, and then a vote on my amendment. My hope is we will be able to do that today.

Mr. President, I yield the floor.

Mr. President, my colleague is apparently going to win a debate we are not having: that this is a bill that will allow the import of prescription drugs from any country around the world. I don't know of that piece of legislation, but if it exists, I will be happy to vote against it. That is not what this amendment is. This amendment doesn't allow imported drugs from anywhere around the world at all. So I am not interested in losing a debate I am not involved in. This debate is about a piece of legislation, carefully constructed, in which we allow imported drugs from countries which have been judged to have a safe supply of drugs.

Let me give an example of testimony from David Kessler. I would say if you could find an expert better on these subjects than David Kessler, I would like to hear the name. He ran the FDA for 8 years and has been identified by everybody as an outstanding FDA Commissioner. Here is what he says. The Dorgan-Snowe bill provides:

A sound framework for assuring that imported drugs are safe

and effective. Most notably, it provides additional resources

to the agency to run such a program, oversight by the FDA of

the chain of custody of imported drugs back to the FDA-

inspected plants, a mechanism to review imported drugs to

ensure that they meet FDA's approval standards, and the

registration and oversight of importers and exporters to

assure that imported drugs meet these standards and are not

counterfeit.

All of this discussion about counterfeit that is happening today, under today's rules, without importation. That is a specious issue. Dr. David Kessler says it provides a sound framework for assuring that imported drugs are safe and effective.

Let me show you a chart from Dr. Rost. I mentioned earlier that they have been doing this for 20 years in Europe. Dr. Peter Rost, former vice president of marketing at Pfizer, said:

During my time responsible for a region in northern Europe,

I never once--not once--heard the drug industry, regulatory

agency,

the government, or anyone else saying that this practice was

unsafe--

He was talking about importation of prescription drugs. If you are in Germany and you want to bring a drug in from France, you can do it through what is called parallel trading. If you are in Spain and want to bring a drug in from Italy, you can do that. So he said not once has anybody raised the issue that this practice was unsafe.

He also said:

Personally, I think it is outright derogatory to claim that

Americans would not be able to handle reimportation of drugs,

when the rest of the educated world can do this.

That is the fact. One other thing: the Congressional Budget Office says this amendment will save $50 billion in 10 years. The leading expert says there is no safety issue. We have a regime in this bill that provides for safety. So the question isn't on all of these ancillary issues--by the way, the Washington Post doesn't take on this issue with respect to safety. It says there is, in fact, a problem with drug pricing. I will read it. They don't want this passed, but the reason is they are worried it will undercut the underlying bill because the President will veto it.

Here is what the President said when he was running in 2000. He was asked:

What about importing drugs?

The President said:

Well, if it is safe, then it makes sense.

Obviously, he was telling those at that debate that he

thinks it makes sense if it is safe. How about consulting Dr.

David Kessler, who says it is safe and effective, as we have

described it in this legislation. So what the Washington Post

says--because the President threatened to veto the bill--they

are talking about ``importation will not solve the problem of

drug pricing.''

Apparently, the Washington Post thinks there is a problem in drug pricing. What is that problem? To respond to my colleague's comments, in the first quarter of 2007 we had the largest price increase in prescription drugs in this country in 6 years. The American Association of Retired Persons, AARP, said in 2006 the price of prescription drugs rose four times the rate of inflation. There is no problem? I think there is a problem. The Washington Post says there is. The numbers show there is a problem.

The question is, Are we going to solve the problem, or are we going to punt it down the road one more time?

Mr. President, I yield 5 minutes to my colleague from Vermont.

Mr. President, I thank my colleague from Wyoming. I regret he cannot be a supporter of cloture and the amendment. I respect and understand his position. We disagree, and I do so respectfully.

I do wish to mention one thing with respect to a pilot program. Following that hearing, I did put together a pilot project and went to Tommy Thompson. I went down to his office and made a presentation of a northern plains pilot project on prescription drugs. He felt like he couldn't move forward with it.

I do want to say what he said to me after he left Health and Human Services. I met him in the elevator outside the Senate Chamber one day after he left being Secretary. I badgered him a lot about the issue of reimportation. As I got off the elevator and he was getting on, we greeted each other. I liked him. I thought he was a good Health and Human Services Secretary. He said: By the way, Byron, you keep working on the imported drug issue. You are right about that. That was after he left Health and Human Services.

Let me again respond with respect to David Kessler. All this talk about safety. First of all, this is where this amendment belongs, on this bill. This improves the bill. It doesn't detract from safety issues at all. It does address something not addressed in this bill, and that is a serious pricing problem with prescription drugs in our country.

There is no answer to this that I have heard in all the discussion. David Kessler, head of FDA for 8 years--I think he is the expert on these issues--said: The Dorgan-Snowe bill ``provides a sound framework for assuring that imported drugs are safe and effective.''

He says they will be safe and effective. Why would someone go to some fraudulent Web site, as was discussed, or maybe go to a bad Web site, why would somebody go to a bad Web site in order to import prescription drugs if a Web site by the FDA exists that would describe where they can access these prescription drugs safely? Those are specious arguments.

The Congressional Budget Office says this amendment will save $50 billion over 10 years. Why would they say that? Precisely because the Washington Post acknowledges there is a pricing problem with prescription drugs in our country. There will be a $50 billion savings over 10 years.

I mentioned that in the first quarter of this year the price of prescription drugs had the largest increase in 6 years in this country. Last year, 2006, according to AARP, it rose four times the rate of inflation.

There is a pricing problem with prescription drugs. The identical drug FDA approved, same pill, put in the same bottle, made by the same company, is sent virtually every other place in the world at a lower price, and the American consumer is told: You know what, we have a special deal for you. You get to pay the highest price in the world.

The question is whether this Congress will decide that special deal of the highest price in the world ought to stop. I hope this Congress will decide we are going to stand with the consumers. Yes, we are going to insist on safety, but we are going to stand with consumers. There is a pricing problem. This amendment is one way to fix that problem in a manner that is safe and effective.

Finally, Mr. Rost says that for 20 years, they did this in Europe. He said:

I think it is outright derogatory to claim that Americans

would not be able to handle reimportation of drugs, when the

rest of the educated world can do this.

Of course, we can do this. Of course, we can allow someone to go to Canada and buy from a Canadian drugstore that has as safe a chain of custody as we do and buy prescription drugs, in this case Lipitor, for half the price that is being charged 5 miles south across the border.

Why on Earth should the global economy not be able to work for average folks? The pharmaceutical industry imports all of these drugs. Why should the average person in this country not be able to put downward pressure on prescription drug prices by being able to access FDA-approved drugs from other countries, such as Canada and other countries, that have a supply of safe drugs. That is what our amendment does. It is the right thing to do.

Mr. President, how much time remains?

Then I yield the floor, Mr. President.

Cloture Motion

Mr. President, as was indicated earlier, the Cochran amendment, with cosponsors, is currently pending, I believe, or has been appropriately offered and is pending. I would like to make a couple of comments about the vote we will have at some point in the future on the Cochran amendment. And what I would like to do is go through so that all of our colleagues understand what is in the underlying bill.

I indicated earlier that one of my colleagues stood up and said the legislation we had offered would allow drug importation from any country in the world, and that is not true. There is no such debate on a bill that doesn't exist.

Mr. President, I have a piece of information distributed by Pfizer Corporation that is opposed to my amendment. It describes various problems with the drugs that are purchased online and counterfeit drugs, and so on. Interestingly enough, all of these problems would be solved by the legislation I have introduced with all of the safety issues involved. You know these are specious issues because the underlying legislation would address all of those issues.

Now, let me go through a list--this is the list; you won't be able to read it, but I will go through them--of the safety provisions in this legislation. First of all, with imported drugs, drugs imported from other countries, which, as I have indicated, Europe has done for 20 years with no safety issues at all, so we are as competent as the Europeans are in being able to do this.

Our bill would require that all imported drugs be approved by the Food and Drug Administration. So we are not talking about any renegade drugs, all FDA-approved drugs, all of them imported be approved by the

I won't speak at length. I do want to make one point. The Senator from Mississippi indicated the amendment I have offered would allow for the reimportation of drugs that are not FDA approved. I don't know where that information comes from, but it is demonstrably untrue. I don't want there to be a mistaken impression on that. I ask my colleague from Mississippi if we could at least resolve that issue. The intent of this, the written version of this, is very clear. No drug will be imported into this country unless it is FDA approved. My colleague indicated this amendment would allow drugs to come in that are not approved. I don't know where that information comes from. If he and I could at least exchange information so that we resolve that, I would appreciate that.

Mr. President, that is a different issue. The amendment itself, whether there is a regulatory framework or not, will not allow a drug to be imported that is not FDA approved. That is the written provision in the amendment itself.

Second, with respect to cost, we may have a disagreement on that, but I again observe that the Congressional Budget Office this morning has given us another score, and the score from the Congressional Budget Office says this will save the Federal Government $10.6 billion in a 10-year period. I believe the global savings--the rest would be for consumers--is slightly over $50 billion in 10 years. So it seems to me it is self-evident. If the Congressional Budget Office is putting out information to the Senate this morning that describes the amount of savings, in this case averaging about $5 billion a year,

it is quite clear, someone is going to save something somewhere. I think we also can resolve the cost issue at some point down the road.

Let me say, I respect the Senator from Mississippi. He is a very worthy legislator, cares passionately about the things he works on. I do the same. I think the way to resolve this is to talk through what are the safety provisions in the bill. If they are inadequate, demonstrably inaccurate, I will accept that we would make some changes. But I do not believe that is the case. I do not believe it has been demonstrated.

As I have indicated previously, Dr. David Kessler, who ran FDA for 8 years, says this bill provides a sound framework for assuring that imported drugs are safe and effective. I understand the pharmaceutical industry does not say that. I understand some others do not believe that. I understand and respect that. But I also believe, very strongly, that the evidence is overwhelming. We have added the safety provisions that were raised by Secretary Shalala. We have added the provisions raised by Secretary Thompson.

I believe--and 33 of my colleagues in this Chamber, Republicans and Democrats, believe--we have done a very good job in resolving those issues. This issue almost has a gray beard. It has been around a long time. We have been trying a long time. It is hard to win on this issue. I accept that, and I understand it. But I am hoping that perhaps this is the year in which we might give the American consumer an opportunity to be able to participate in the global marketplace in a safe and effective way, just as the Europeans do, and be able to access a lower price of FDA-approved drugs.

Mr. President, I yield the floor.

Mr. President, one of the observations I made when I was privileged to come to the Senate is that virtually everyone here is a pretty effective communicator. I am reminded of that every day. I hear debate by people who really are effective, and I always appreciate it, and it is always interesting to me.

I do think--certainly everybody is entitled to their opinions; I respect their opinions--not everybody is entitled to their own set of facts. We have to deal with a common set of facts.

My colleague just made a statement, a philosophical statement, about what he believes. I respect that. But the statement included thoughts like that this piece of legislation would probably abrogate or not respect copyrights. Nothing could be further from the truth. There is nothing in here that would abrogate copyright protection, and so on. In fact, this amendment provides the requirement of serial numbers on lots and samples by those who are engaged in this sort of thing that has been prevented from occurring inside this country. It requires it for importation, and it requires it for domestic medicines. This will dramatically change the safety of the drug supply here and with respect to that which would be imported.

With respect to the American people, the American people are not undecided on this issue. Mr. President, 70 or 80 percent of them believe there ought to be allowed the importation of prescription drugs. This is not something the American people are undecided about. It is only in this Congress that it has not been decided. So I think that is something we should understand. Why would the American people believe they should be able to import FDA-approved drugs? Because they believe it is fair for them to be able to do it.

Let me describe where the prescription drugs come from by the manufacturers of the drugs. If you are taking Lipitor, that is not made here; that is made in Ireland. If you are taking Toprol XL, that is made in Sweden. Nexium is made in France. Altace is made in Malta. Vytorin is made in Singapore and Italy. These drugs are already imported. Regrettably, by the way, I might say they are imported without the protections that would exist in our amendment. It would require the manufacturer--the manufacturer of the drug--to have serial numbers on the lots, to have samples of every lot reserved, to have a pedigree for every medicine that is moved. That is for domestic consumption. I am not talking about the imported drugs under my bill; I am talking about the drugs that are made in these countries and other countries that ship them into this country, and every drug that is produced in this country will require the same.

The fact is we have tried to get that same requirement on domestic drugs and have been blocked for a long time. This legislation will make the drug supply in this country far more safe than it currently is.

We all know the amendment that is being offered about risk. Were that amendment to be offered with respect to new prescription drugs that come from research to say, you can't put a drug out there if there is risk, do you think you would have a new drug on the market anytime soon? Do you think a Health and Human Services Secretary or an FDA administrator can say: By the way, I am approving this drug and there is no risk. Of course, they can't. Of course, they would not. We know that. Drugs have risks. In fact, some drugs are put on the marketplace, and we discover later they should not have been there--a substantial risk. Vioxx. An official at the FDA says he believes 50,000 to 70,000 American people died of heart attacks as a result of Vioxx being put on the market. Further, he says--this isn't me, this is an official at the FDA--that Vioxx was widely advertised and widely promoted as some wonderful new drug, when in fact it was not a new class of drugs that had any significant benefit over existing drugs. The point is this: If one were to ascribe this risk category to new drugs, there would be no new drugs.

I know all this talk about counterfeiting--and man, have we talked a lot about counterfeiting in this Chamber in the last couple of days-- all this talk about counterfeiting ignores the point that it is occurring under today's laws. The way to fix that and the way to stop counterfeiters is to do what we do in this amendment: You require on every prescription drug that is sold, that it have a pedigree. You require in every circumstance there be serial numbers on lots and samples. It is incontrovertible, in my judgment, that this will dramatically improve the safety of domestic prescription drugs as well as imported prescription drugs.

One final point with respect to the issue of research. My colleague said: Well, if we pass this amendment, what the Senate has said is there is no value to research on prescription drugs. I don't have the foggiest idea where that concept comes from. We spend a lot of money on research. I was one of a group of Senators who said: Let's double the amount of money at the National Institutes of Health, and we did, in 5 years, to dramatically improve and increase the amount of research at the National Institutes of Health. I am a big supporter of research. We do a lot of wonderful research, some in the public sector, some in the private sector.

At the NIH, by the way, we do the research and often much of that research is used by the pharmaceutical industry to produce lifesaving drugs. But lifesaving drugs save no lives if you can't afford to get them, if you can't afford to have them, and if you can't afford to take them.

It is true none of us have a problem, in this Chamber, dealing with the price of drugs; we have health care policies and those kinds of things. But there are a lot of folks all over the country who are taking a lot of different prescription drugs. I think prescription drugs are wonderful. They keep people out of an acute care hospital bed, the most expensive kind of health care. Interestingly enough, in many cases they are taking 10 or 12 different kinds of prescription drugs to manage various diseases. As a result of that, we passed Part D; my colleague is correct about that. Part D provides drug benefits to those who have reached the age of Medicare. Regrettably, of course, there was nothing in Part D that would put downward pressure on prescription drug prices. I would say look at the increase in prescription drug prices in the first quarter in this country. Look at the increase in prescription drug prices in 2006, and then ask yourself whether all of this is working to put some downward pressure on pricing. It is not. It is just not.

So as I said earlier this morning, I hate to lose a debate I am not having. I would love to have a debate in which we are both debating the same bill, but a suggestion somehow that this bill allows drugs to come into this country that are not FDA-approved means that you are off debating some other bill someplace. Well, fine. Win that debate if you want. It is not the bill that is on the floor of the Senate. It isn't. The same is true with a number of statements that have been made about respecting copyrights, and so on. In fact, what we have required is a regulatory burden that the industry doesn't like--I understand that-- but it will, in fact, protect them and protect their copyright because it will make it much harder for anyone to counterfeit. That is a fact.

One of the interesting aspects of this country is that we are seeing some unbelievably good news. The good news is people are living longer and better lives. In a century, in 100 years, we have increased the lifespan by somewhere around 30 years, from 46 years old to about 76 years old. That is good news. People are living longer and better lives. A significant part of that, I think, is being able to, at an advanced age, manage diseases. A significant part of that is prescription drugs. There are some who don't have that. I have an uncle I have described before who is now 86 years old. He and his wife take no prescription drugs at age 86. The fact is, as I have also described to my colleagues, he is a runner. He runs in the Senior Olympics at age 86. He used to run in his seventies and early eighties the 400 meter and the 800 meter. Now he tells me he is a specialist in the 100-meter dash, at age 86. He has a good life. He is healthy. He likes life. He is very active. He is not riding his motorcycle so much anymore, but he has one of the biggest motorcycles you can get sitting in his garage. He doesn't need to take prescription drugs. Good for him.

We have a lot of folks who reach their eighties and nineties. We know about that because in our part of the country, my State of North Dakota ranks No. 1 in the Nation in the number of people 86 years of age or older as a percent of the population. We rank No. 5 in the country in the number of people 65 years of age or older as a percent of the population. So a lot of people are living a lot longer. That is good news. It puts some drain on Social Security and Medicare.

A quick way to fix Social Security and Medicare is to go back to the old life expectancy, go back to age 46. We wouldn't have any trouble. I am digressing a bit, but when Social Security was created, on average, people lived to be 63. So we created a system that says: When you retire, you get benefits at 65. Well, I went to a small school, but I understood enough in math to think that works out real well. You pay taxes and, on average, you are going to live to age 63, and when you retire at 65, you get some benefits. That is not a system that is going to have financing trouble at all. But then the problem is people began living much longer. That is not a problem. That is a success. So good for them.

At any rate, prescription drugs about 40 years ago became a much larger part of the discussion in modern life, to keep people out of the acute care hospital beds and to manage their diseases. So that is a wonderful thing. I have said before, and I will say it again: The pharmaceutical industry is a fine industry; I have serious problems with their pricing strategy. I think it is wrong. I want them to succeed. I want them to research. I want them to do the research on prescription drugs. I would like them to stop advertising early in the morning when I am shaving and brushing my teeth and getting ready for work, telling me what I ought to go talk to my doctor about. They have all these pills they want me to ask the doctor if they are right for me. I get confused. I am not sure I need them. But there is a lot of advertising going on and a lot of promotion.

I want them to find new medicines to unlock the mysteries of dread diseases. I want the Federal Government, through the NIH, to substantially invest in new research and development. I want all of those things. But I also want, even as I compliment the pharmaceutical industry and I compliment the NIH and all those who are spending their days--today, Thursday--trying to figure out how do you unlock the mysteries of ALS or diabetes or cancer or heart disease, even as I do that, I say to the pharmaceutical industry: I think your pricing strategy is wrong and it is unfair to the American people. We ought not be paying the highest prices in the world for prescription drugs. That is unfair.

The amendment I have offered with 33 of my colleagues, Republicans and Democrats, would change that. No, it wouldn't shut down research, not at all. No, it wouldn't exacerbate counterfeiting, not at all. The fact is this will be fair to the American people, if we pass this legislation. It will continue, I think, to see substantial research. It will also, in my judgment, contribute to shutting down the counterfeiting of prescription drugs, but most importantly, it will finally say to the American people that we are on your side on this issue. We believe in fair pricing and we finally are going to insist on it.

I yield the floor, and I make a point of order that a quorum is not present.

Madam President, I would like to offer a few comments about this subject. My colleague has spoken on it several times. As I have indicated, we all want to deal from the same set of facts. This is not--let me emphasize again--it is not importing the standards of other countries with respect to the safety of prescription drugs. It does not do that. I want to make sure everybody understands what the facts are. Everyone is entitled to their own opinion; everyone is not entitled to their own set of facts. This does not import the standards of some other country into this country with respect to the safety of prescription drugs. This is simply the question of whether we want to continue to have FDA-approved drugs made in FDA-approved plants; that is, a plant inspected by our Food and Drug Administration, producing medicine and put into a bottle that is approved by our Food and Drug Administration and sold in this country and the same medicine, in the same bottles, sold in France, sold in Italy, sold in Germany, sold in Canada, sold in England, to have the U.S. consumer pay the highest prices of all of those countries. Is that fair to the U.S. consumer? The answer is no.

We have a lot of issues that are being raised on the issue of safety. All the things I have heard discussed on the floor of the Senate apply to today--now--when we don't have importation. We are not able to import safely. I should say we are not able to import, rather, prescription drugs because there is a prohibition against it. The only entity that can import a prescription drug is the manufacturer. Lipitor. I held up two bottles of Lipitor on the floor today. Lipitor is made in Ireland. They send it all around the world. They send it to Canada and they send it to the United States. The bottle looks the same, the pill looks the same because it is the same, and it is sold under the same chain of custody--Canada and the United States. There is only one difference. The U.S. consumer is treated to double the price when they purchase their Lipitor. Is that fair? Should we pay twice the price for an FDA-approved drug? I don't think so.

My colleagues have said there are counterfeiting issues. Well, all of the stories that have been recounted about counterfeiting issues are occurring under today's schematic of prescription drug sales in America. This has nothing to do with importing. In fact, the legislation I have offered is legislation that would make the supply of prescription drugs in this country and the supply that would come into this country under reimportation much safer. They would be safer because we have put in place safety procedures that have previously been blocked in the Congress, establishing serial numbers on the supply of prescription drugs, samples of the supply of prescription drugs to be held back by those who are manufacturing and moving the prescription drugs, establishing a pedigree for all of these drugs and the bottles in which they travel. It is much safer. It will be much safer for the domestic supply in addition to the supply of imported prescription drugs. That is the point we make.

I suppose people will be tired of hearing me say that I respect those who have a different opinion, but I would prefer if they would stand up and say: You know something. Here is my situation. I think the American people ought to pay twice the cost for Lipitor because I believe that. That is a pricing strategy that works for my constituents.

I don't hear anybody saying that, of course. They stand up and say there will be big safety issues, or my colleague who in an earlier speech this

morning said this amendment would allow drugs to be imported into this country from all over the world. I am sorry. That is not right. That is not debating the bill that exists. We are not letting drugs in from all over the world; only from countries that would qualify, that meet the safety standards. These would only be FDA-approved drugs, and they would only be drugs that are retained under a chain of custody, with a pedigree attached to the drug. There are no safety issues, unless one thinks it is unsafe for the pharmaceutical industry not to make the profits they currently make. They perhaps would see some smaller amount of profit if they passed part of the lower cost along to the consumers.

Maybe perhaps the industry could do a little less advertising, just a little less advertising. When you turn on the television at night and you sit down at the end of a long day and you see somebody driving in a convertible with beautiful people and they park under a tree someplace and the Sun is setting, it is a beautiful appearance, and they say: These people are feeling good because of medicine they are taking. You should be asking your doctor whether you might want to take some of that. Get some of this pill. Get some of this medicine. The Sun shines, you get to ride in convertibles, feel better, hang around beautiful people. That is the way advertising works, I guess. I have talked about the purple pill. They say: Ask your doctor, is the purple pill right for you? I don't know what the purple pill is, but I almost feel like asking the doctor, is the purple pill right for me? All of this promotion and advertising, maybe they could back off a little bit of that and reduce the prices to the American consumer. But that is not the strategy.

The strategy in pricing prescription drugs is that almost every country has some kind of limitation on what can be priced with respect to prescription drugs, except the United States of America, and here it is Katie bar the door. Whatever they want. We do have price controls in America. Not imposed by the Government; price controls by the pharmaceutical industry.

Now, this is a fine industry. They have men and women working, trying to unlock the mystery of diseases, trying to find ways to produce medicines that will manage diseases. I admire all of that. I say congratulations to them. But I have a serious disagreement with them on pricing strategy. They are wrong to believe they have to charge the highest prices to American consumers. That is a fact. They are wrong about that. They say: Well, it is the only way we can do research and development. That is not true at all. That is not true. A substantial portion of research and development is done by the taxpayer through the National Institutes of Health and others, and the product of that is turned over to the pharmaceutical manufacturers in terms of intellectual property that is developed and they manufacture drugs. Good for them. I know they also do substantial research on their own and I appreciate that. I don't appreciate the pricing strategy because I think it is unfair to the American consumer.

I don't know how many people I have talked to over the years who have come up to me and told me of their problems: I am 80 years old. I have heart disease. I have diabetes. I take all kinds of medicines, they say, but I can't afford them. The doctor says in Dickinson, ND, one night: I have this welfare woman, and this patient has a pretty aggressive form of breast cancer. He says: You have to be taking this medicine to prevent a reoccurrence when you have surgery. You have to take this medicine to prevent a reoccurrence of breast cancer. She says: What does it cost? He tells her. She says: I can't possibly do that. I can't possibly take that. I don't have the money to do that. I can't buy that medicine. Does this matter? It sure matters to the person whose life is at stake. So price is an issue. It is a big issue.

We have all these anecdotal stories. We know the data. The amendment I have offered will save $50 billion over the next 10 years--$50 billion--most of it to consumers, through lower drug prices. That is a fact. It is not going to, in any way, injure the safety of our prescription drug supply. It will, in fact, enhance it dramatically by establishing pedigrees with respect to the movement of prescription drugs in this country and into this country. That is a fact as well.

I said this morning I hate to lose debates I am not having, and it happens all the time on the floor of the Senate because someone is debating a bill I didn't introduce. They are welcome to do that. If it is attractive, maybe I will introduce it someday, but I am not interested in having a debate with somebody who wants to reformulate the legislation I have introduced. This addresses safety, all of the issues that Donna Shalala, the former Secretary of Health and Human Services raised, so we have incorporated into the bill, Senator Snowe and I and others have incorporated that right into the legislation. So you can't, it seems to me, make a strong case that there are valid safety issues. Again, I don't have problems with those who come to the floor saying let's continue the current system, but I think the current system is wrong. They have a right to advocate for the current system, but the current system is unfair to the American consumer, in my judgment.

I want us to have the opportunity to have good health care and opportunities to be able to access miracle drugs, the opportunity to use those miracle drugs to manage diseases so you can stay out of an acute care bed, which is the most costly health care in our country. But I think it becomes almost a health care rationing in our country when we say we will ignore the situation that exists in this global economy in which the American consumer pays one price and consumers in virtually every other country pay a lower price for their prescription drugs. That, I think, is a horrible disadvantage to consumers in our country.

Some will say: Well, you know now we have a Part D in Medicare which offers prescription drug benefits to senior citizens. Yes, that is true. It does. It has what has been defined around here only in the lexicon of politics as a doughnut hole. Only in the political system could we use those kinds of descriptions, but it has a kind of a circumstance where you reach a certain level and then there is no drug coverage on up from that level. Obviously, the prescription drug Part D for Medicare is helpful to senior citizens; there is no question about that. But it certainly isn't perfect because there is a substantial portion of it in which prescription drugs are not covered. At that point, senior citizens who are reaching the declining years of their lives are finding it very difficult to purchase their prescription drugs.

There is much to say about this issue. I know there are some who worry that offering this amendment on prescription drug pricing to this underlying bill, the FDA Reauthorization Act, injures the underlying bill. I support the underlying bill. I think my colleagues, Senator Kennedy and Senator Enzi, have done some good work. I support that work. Let me say--and I know they know this--it is perfectly appropriate to offer this amendment on this bill because this is where it belongs. This is exactly where you would offer an amendment of this type. No one should express surprise about that.

So we offer the amendment and then we file cloture so we can actually get to a vote on it, and all of a sudden it is like the circus left town. They pull up the tent stakes, fold up the tent, everybody is gone. All of a sudden we can't vote anymore. Why? I guess they are upset that my amendment is now in order to be voted on, and they say: You know, I don't know. We can't do that.

As I have indicated before, I would be willing to offer this amendment in a different form--the same amendment but in a circumstance where I had an agreement to be able to bring it up. Four hours of debate, for example, a couple of amendments that would be offered by the other side, I would have the right to offer second-degree amendments, we would go to a vote and decide whether the Senate will pass a proposition that would give us an opportunity to reimport FDA- approved drugs from other countries that are identical to the other drugs we now purchase, except at a lower price. I would be happy to agree with others who would give us that time and that circumstance so that we could have this vote. I don't need to have the vote today or Monday or Tuesday, if I have an agreement that we will be able to get the vote at some moment.

This vote has been stalled a long while. Senator Frist, when he was the majority leader, standing right back here at the end of this aisle at about 1 o'clock in the morning, in exchange for my releasing a hold on the nomination of Dr. McClellan, indicated to me and then put into the Congressional Record, in the Senate Record, that we were going to have action on this kind of legislation. It turns out it never happened. Senator Frist, of course, is now gone. For whatever reason, it never happened. I spoke at great length to him about these issues, but it didn't happen.

So this is an opportunity for us to advance this legislation, and it is the right place at the right time. This has 33 cosponsors. John McCain is a cosponsor, Ted Kennedy is a cosponsor, Chuck Grassley is a cosponsor, Debbie Stabenow is a cosponsor, and Olympia Snowe is the major cosponsor with me. It is the Dorgan-Snowe bill.

Thirty-three Republicans and Democrats are cosponsors of this legislation. This is exactly where it should have been offered, and it was. Now, all of a sudden, apparently there is some kind of gastric distress because we had a cloture vote and we prevailed in the vote that we say, all right, let's have votes on this amendment. So my hope is that, first, while we might form opinions on this amendment, we could coalesce on a central set of facts that represents what the amendment does and says; and, second, that we can begin, on behalf of the American people, to make some movement here and to begin to have votes.

I also hope that, as I listen to further debate on the floor, we can stick to what the amendment is. It is not to reimport lower priced FDA- approved prescription drugs from everywhere. It limits it to those areas where we have safe and effective supplies of prescription drugs.

I hope we can get all of the facts straight. This amendment has a lot of support. I believe the American people, by 75 to 80 percent, support this. I have seen poll after poll where the American people believe it is wrong and unfair for them to be charged the highest prices in the world for prescription drugs. Why on Earth should they drive 10 miles between two drugstores--one on the Canadian side and one on the American side of the border--only to find that the same medicine, put in the same bottle, made by the same company, FDA approved, has only one difference--the American consumer gets a chance to pay double. How do you justify that? You don't. We ought to change it.

I yield the floor and suggest the absence of a quorum.

Certainly.

Mr. President, I yield 10 minutes to the Senator from Mississippi.

Mr. President, I yield 5 minutes to the Senator from New Jersey.

I yield 4 minutes to the Senator from North Carolina.

Mr. President, what is the time situation?

Mr. President, I rise to oppose cloture on the amendment. I find it ironic that in the midst of the work on the biggest drug safety reform in the last decade, perhaps longer than that, we are even considering the issue of drug importation.

Our drug safety bill is an acknowledgment that we don't have things quite right in our domestic drug safety system. I am baffled that we want to take on all the hard work and effort to fix our drug safety problems and throw it away by opening our borders to foreign drugs.

When I was Chairman of the HELP Committee, we held three hearings on drug importation. The witnesses at the hearings raised a number of problems and questions about importation in general, and this bill in particular. In fact, one of those hearings was entirely about this bill. At that time, I asked my colleague from North Dakota if he would work with me to develop a State-based pilot program for drug importation. He turned me down. He was convinced then, as he is now, that this bill is the way to go. I would like to take these kinds of proposals in small chunks, if we are going to have to take them, to ensure we don't create a large-scale disaster. I hope we are not going to create a disaster here by accepting this amendment without further consideration.

I respectfully suggest that this bill is not the way to go, and even if it were, this isn't the time for it to go there. We have heard a lot of comments about the Washington Post editorial, and I refer people to that editorial. They

cover a number of factors, but they do emphasize that the main bill, the safety bill--the FDA safety reform bill that we are working on--is a very important bill. They do recognize this amendment would add some very strong complications to it. The Senator from North Dakota suggests we read the bill. You know, that is a good suggestion for anything we cover around here. I make an effort to read all of the bills we do, and I have read this one. I hope everybody takes a look at this one.

I think you will vote against cloture if you read the bill. It is a roadmap to loopholes. Yes, every time somebody brings up a potential safety issue, they stick another clause in there that might cover that gap. But it shows where the gaps are most likely. They keep adding paragraphs to try to patch up these loopholes. We have an amendment that would have been a second degree, but it was too late for it to be submitted as a second degree, so it is a first-degree amendment that would deal with anti-counterfeiting.

That is another area that has to be looked at carefully. The Senator from Vermont talks about taking people into Canada to buy drugs. Well, you know they are going to the exact pharmacy at that point. They are not going through the Internet or through the telephone. These drugs can be intercepted--there are false sites that are set up out there, and people may think they are getting drugs from Canada, but are actually getting them from Saudi Arabia and other places around the world. It is so easy to get information and believe it is coming from a particular location--they may even imply it is a particular location to get the consumer's confidence. There are so many ways they can mislead consumers and it may not be that location. To try to solve some of that, Senator Gregg has an amendment that would perhaps tighten up the Internet problems. But look at that, too, and you will see there are problems if you are not getting it directly from the pharmacy.

I am a strong supporter of people getting drugs from their local pharmacist, the one who will help you interpret all of the sheets of paper that come with the prescription. They are going to know what other drugs you are taking and if there are possible interactions. Local pharmacists are the most valuable asset we have in the entire pharmaceutical chain. But bills like this work against them and may have consequently put them out of business. That is going to be a tragedy for America.

I have read the amendment. I encourage people to read it and look at the complexity of the amendment and look at the loopholes they are suggesting they have fixed. See if you think this patchwork fixed them. But I also ask that you look at what the Washington Post said, and I am not one of those who normally advocates that you listen to what they say. But it is definitely food for thought on this bill. It will take away a major reform that we could have by throwing something else in that we need to discuss more.

I ask my colleagues to oppose cloture for the sake of the safety of our drug supply. Let's get it fixed at home before we try to open it up to the world.

Mr. President, how much of my time remains?

Mr. President, in order to allow the Senator from North Dakota to have the final word, since it is his amendment, I ask people to vote against cloture.

I yield back the remainder of my time.

I object.

There is still a lot of work being done on this amendment. Senator Kyl and others are involved in it and would not want the debate until we had more chance to work on it.

Madam President, what we are actually on, of course, is the 30 hours of debate postcloture on the drug importation amendment, and I do want to make some comments on that. I perhaps should have done more extensive debate before, rather than agreeing for a time specific for a vote on it, but that option has passed at the moment. I congratulate Senator Dorgan for his tremendous victory.

I am hoping there will be some changes yet. Perhaps there will not be. We took a 300-page bill that dealt with drug safety in the United States and we then added a 140-page bill that deals with bringing in drugs from other countries. It is a limited number of countries, to start with, but it is bringing in drugs from other countries. I suggest if they are as safe as what we have been told, parts of this bill would not exist.

For instance, page 48, on bioequivalence. It was my understanding what would be brought into the United States would be drugs from companies from the United States that went to Canada, or went to some other place, and could be brought back into this country. These would be FDA-approved drugs. These would be the ones we rely on the FDA for. If they are exactly the same drugs, by exactly the same company, why would there be a section on bioequivalence?

It says:

. . . if the Secretary determines that the qualifying drug

is not bioequivalent . . . the Secretary shall . . . include

in the labeling provided under paragraph (3) prominent

advisory that the qualifying drug is safe and effective.

Well, let me see. We didn't ask them to review it, we didn't ask that it go through the same procedure, but we want the Secretary to provide labeling that says it is safe and effective. I don't know why we would expect the FDA to say anything that is bioequivalent should have their endorsement of being safe and effective. If we do, it expands their job dramatically and there ought to be resources that go with it to be sure that what we are promising will be done gets done.

There are a lot of pages here, a lot of different things. I am definitely not going to hit on all of them, but I am going to mention a few that people probably ought to be a little concerned about.

Here again, on page 56, I thought it was going to be U.S. drugs, or at least drugs from U.S. companies that are already FDA approved that we were going to make sure there was an absolute chain of making sure they got back into the United States so that you could trust what came from U.S. companies. Yet on page 56 we see:

Notice; drug difference not requiring approval.

What?

. . . supplemental application would not be required for

the difference to be made to the U.S. label drug, or that

states that there is no difference.

And then a whole bunch of requirements again for the Secretary, which goes down the line to the FDA. So I think we can conclude we are not just going to bring in U.S. drugs. If there is anything you would like to have, you can.

Then there is a section called ``Importation by Individual.'' This covers the portion where each person can get on the Internet or telephone or whatever way and order drugs. There are requirements in this bill for exporters, which are the people who are sending drugs to other countries; there are requirements in here for importers, which are companies receiving drugs--and those could be pharmacies, probably would be pharmacies, although there could be some wholesale--but there is also this section about importation by the individual.

I hope everybody takes a little look at that, because in the United States I have been working a lot on financial literacy, trying to get people to understand finances and how they can stay financially sound and hopefully financially secure, and it is a huge job. With regard to the No Child Left Behind Act and in Education, we keep talking about plain old literacy; just being able to have people read, and read at grade level, and hopefully read well enough to have a good job and to protect themselves. They better be literate, because look on page 62 and read what the importing individual is responsible for. Because if they are not responsible for this, they could easily be getting something that is not an approved drug or that is not from the source they think it is. It could be a counterfeit drug, and particularly as this opens up on the front end. How many people doing counterfeit drugs now are going to want to jump into the breach and catch people before they understand any of this? I suspect there will be a huge escalation of companies getting into the counterfeit business. There are a few dollars in it--quite a few dollars.

I would encourage people to look on page 62. There are things scattered

throughout the bill an individual would have to know to be sure what they were getting was safe, if they ordered individually. But that is kind of the point of the bill, because most of them probably will be ordered individually.

On page 64, Request for Copy of Special Labeling and Ingredient List. I think that probably would be handy.

Then, on page 65, it goes into the question of adulteration, where it says a qualifying drug that is imported or offered for import shall be considered to be in compliance if the drug is in compliance with all these other sections.

There is also a section titled Standards for Refusing Admission. There are quite a few ways it can be denied, but in order for these adulterated drugs to be denied, to be refused admission, somebody has to find them. So what kind of force are we going to add to the FDA to make sure these things can be found?

I am particularly fascinated with item (F), which gives the Secretary some extra capability if the drug is counterfeit or if the drug may have been prepared, packed, or held under insanitary conditions. Now, the fact that they mention it has to make you believe there is a possibility--maybe a probability, the way it is put in here--that they will be prepared, packed, or held under insanitary conditions.

The United States has a little different level of sanitation than a lot of the countries around the world. Of course, all of these aren't going to come from all around the world to begin with, or will they?

Let's see. They do not have to be bioequivalent. There are a whole bunch of things the individual has to watch out for themselves. It doesn't have to be the same drug that was manufactured in the United States or from a United States company, and if it gets into the EU, it can come to us. That is EU now; EU later. The EU is expanding. We ought to take a look at some of the countries that are being brought into consideration, particularly if you might be worried about them being packed, held, or prepared under insanitary conditions.

Then we get to page 71. Again, there are a lot of things I would like to mention in between, but this is all boring detail stuff, anyway, so I will highlight a few of these things and let people think about them a little bit.

On page 71, we give the Secretary some more responsibilities. They have to:

. . . enter into an agreement with the government of the

country to receive information about recalls and withdrawals

of qualifying drugs in the country; to monitor recalls and

withdrawals of qualifying drugs in the country using any

information that is available to the public in any media.

There are requirements for notice and changes in the labeling, packaging, and that sort of thing.

That is all additional. We are asking them to do some more things in the United States to make what we have here and are relatively certain about even safer. That is the purpose of the bill. Now we are adding these additional sections, 140 pages, which bring the problem from other countries to our country. I grant it, a lot of those are made in the United States or by companies from the United States.

Page 72, again, has a whole bunch of requirements for what kinds of things ought to be included with the drug. You need to know those because if they are not, you maybe ought to suspect there may be a problem. You have to be able to check the packaging and note whether it has the proper seals and whether there could have been any damage to them. It is your problem--unless, of course, the consumer consents to waive the requirements after being informed the packaging does not comply. There is fascinating stuff in here.

Here is one of the parts that really ought to interest us. When we get to page 76, page 76 says you have to play the game: You can't win, you can't lose, and you can't get out. Here is how that works.

Canada has price fixing. There is no doubt about it. That is how they get some of the lower prices on some of the drugs. You can't buy all of the drugs in Canada at lower prices. In fact, I have a friend in Afton, WY, who is a pharmacist. He had a fellow come in who was from Canada but he could not get back to Canada and his prescription had run out, so he relied on an American pharmacy to get his prescription refilled. All the time they were filling the thing, he is complaining about how this darned prescription is going to cost him an arm and a leg because it is in the United States and the cheap drugs are in Canada. The pharmacist gave it to him, told him what the price was, and he said: But that is cheaper than I get it in Canada.

That is a little bit of financial literacy. Just because you heard everything is cheaper in Canada doesn't mean it is.

You should particularly pay attention if there are generics because U.S. generics do not translate to Canada nearly as quickly, if at all. The companies had to go through this bidding process. The bid doesn't take into consideration the change, and that is part of the deal, that you get a little bit of exclusivity with your pill.

I was interested in Zocor. It is a big drug in the United States and a big drug in Canada, although Canada has one-tenth the population of the United States. The Health Minister called me and said: You cannot be considering this import thing. We do not have the capability to supply the United States with their drugs. We will be inundated with prescriptions, and we do not have that big of a supply because we have a tenth of the people the United States has.

Getting back to my Zocor story, that has gone generic. In Canada, you still have to get Zocor, and it is $33.64 for 30 pills. That is a 1- month supply of 10-milligram pills. That would not, of course, include the cost of shipping and handling.

In the United States, there is a generic Zocor, simvastatin. The statins are all designed so that part of the label talks about doing similar things. But the generic Zocor in the United States costs $29.99 for 30. So that is $3.50 less. It is not a lot, depending on what you consider a lot to be, but it is less. But if you are willing to use provostatin or lovastatin, we are talking about $4 a month--$4 a month as opposed to $33.64 a month.

People need to be aware that just because we say Canada is cheaper, it is not always cheaper. But for those drugs which are cheaper, page 75 has a little provision.

I need to explain how Canada gets this price fix. It is called negotiated price. How do you negotiate a price if there is a sole supplier? You really do not have much luck negotiating if it is a sole supplier, so you have to take similars. I use the example that if there are five heart medicines, you make those five bid against each other. That is your leverage. If you make them bid against each other, you have to drop somebody to get the price down, and probably several to get the price down, so maybe you have one or two heart drugs instead of five. But you tell your doctors--who in Canada work for the state--that is their choice, and they make it.

But in the United States, we are used to having our doctor make the decision. And because of television advertising, we are able to make some of our own decisions on what we think would be the best one and tell our doctor what he better do for us. Sometimes that is another little problem.

At any rate, that is how Canada gets lower prices. We can probably do that in the United States, too, but people in the United States really expect to be able to get the drug their doctor says they ought to have. I think we would have a large-scale revolution if we started suggesting that the Government could figure out which drugs they could have so we could get lower prices.

Page 75, section (b), that is where they say if a company has a drug that is in Canada, it has to be sold in the United States at the same price. So you really do not have to go through Canada. That will just move Canada's price fixing down to the United States.

I have to mention a little thing on pricing when the Government gets into that business. Back in 1975, I got married, and my wife and I started a shoe store in Gillette, WY. You will recall at that time that the Government decided they would put some prices in there. This really shows that it was 1975. We always made sure there were several styles of men's shoes that were under $10. I don't know if you can get the laces for $10--yes, you can. But you

cannot buy $10 leather shoes, leather lined, particularly not made in America. That has disappeared, too.

But they decided, for a whole range of products in the United States, that the Government would set the price to keep down inflation. The companies, as soon as they heard about that, said: This will really affect our profitability, and we are not going to be allowed to raise them except at set particular times and for set amounts. So what they did was raise their prices right away. A $10 shoe became a $15 shoe overnight. Then the price setting went into effect and they were allowed to raise it again, and they raised it again to the maximum there. And every time they were allowed to raise it, they raised it. It made a huge difference in the price of shoes, as it did with everything that was being attempted to be controlled. People wound up paying a lot more than if there had been no Government pricing.

How will that work here, if you are a pharmaceutical company and they say that you are not going to be able:

. . . to discriminate by denying, restricting or delaying

supplies of a prescription drug to a registered exporter or

other person in a permitted country that exports a qualifying

drug to the United States under this section. . . .

And you can't:

discriminate by publicly, privately, or otherwise refusing to

do business with a registered exporter or other person in a

permitted country that exports a qualifying drug to the

United States under this section . . .

And so on. I am reading from the bill here. What it says is that if you are selling it to them now, you can't change at all.

If I am the company that is about to find out that the price I have in this deal with Canada, which is just a small part of the deal, and I am doing it--I am the only accountant in the Senate. For accounting purposes, sometimes these companies will sell to another entity a ways away--in this case, another country--for a lower price because they cover the costs and make a profit on what they are doing. But by picking up peripheral sales, there is less cost involved in them, so there is still the same amount of profit. Granted, that is kind of an accounting technique, but it is the way a lot of businesses have to pick it up. That is why they keep going for additional sales and looking for ways to get additional sales. They have gotten additional sales in Canada by going through this bidding process which fixes the price.

But what we are saying on page 75 of this bill is that if you sell to Canada, you have to keep selling, you have to keep selling at the same price, and you cannot get out of the game unless--and here is the ``unless'' that I bet you kicks in--unless you are not selling to them. So unless there is some kind of ironclad contract that requires them to continue to do that, Canada is just about to lose its drug supply because they are not going to continue to sell up there at a rate that is below cost--if you are doing it at U.S. costs--if you can jerk that drug.

That is why Canada is a little bit concerned about what we are doing here. First of all, they don't have enough drugs in the pharmacy and enough pharmacies to supply 10 times their population, for the people in the United States, and second, they are worried because their supply will be cut off before this bill goes into effect, so it really doesn't go into effect. That would be the effect of it, that this would be 140 pages of wasted trees.

You have to believe, unless there is an ironclad contract, that is what a business would do. It is a terrible thing to have happen to Canada or the other countries. But that is what happens when you fix prices.

I would mention that on page 115, it begins a section on Internet sales of prescription drugs. I will give them credit for giving it a try. I will not give them credit for having a very complete or safe job on it, but it is a try. It is important for them to try because most of the people in the United States will be ordering their drugs, probably, through the Internet--perhaps over the telephone but not in person.

The examples we have heard of everything working fine have been of people going across the border in a car and buying at a pharmacy. That makes sure the trail of concern and safety is more likely to be there. But the Internet is a little bit more universal. Things can go around the world in a matter of minutes. They can go from one server to another server to another server--you are now covering three countries--and it looks as if it came out of the last country, perhaps, if you want it to look like that. There are a lot of things that can be done. I know the kids would probably understand that more than I would because they are able to do a lot more things on the Internet than I am able to do on it.

I know there are some difficulties with the Internet because the FDA has already intercepted problems and been able to confiscate some drugs that were tremendous problems. They are pretty sure some got into the country and didn't wind up in a situation of death, but they did find out they wound up in a situation where the person was not getting what they thought they were getting and it wouldn't digest and problems such as that. But they have also confiscated a huge amount of drugs which have been sold over the Internet which came into this country and which have a lot of problems.

I had a display up here on the desk. The Senator from North Dakota likes to hold up two pill bottles and say: What is the difference between these two pill bottles? One is the United States and one is Canada. What is the difference in price? And he goes through the pricing difference. But one of the things he ought to go through at the same time is: Can you tell which was made in the United States and which was not? Can you be sure the one you say was made in Canada was made in Canada? I will tell you, there are some absolutely marvelous counterfeits out there.

The box I have here has a couple of examples of confiscated drugs from the FDA. You cannot tell by the box, you cannot tell by the packaging, you cannot tell by the pill. I am even told that if you grind it up, you will wind up with the same components; they are just not put together right, so they don't work. But as long as it is not a lifesaving drug for you, you can get along with it, anyway, you just will not be getting the benefits from the drug. Something to think about.

There is a possibility of improving that section, because one of the amendments that has already been filed is by the Senator from New Hampshire, Mr. Gregg, who has been working this Internet problem for a long time. He has an amendment that is a vast improvement over this section and might be able to greatly enhance and perhaps correct some of the problems that can happen there.

I would mention one more. Page 131, a restricted transaction. See if you have the pharmaceutical literacy to know exactly what is happening here. A restricted transaction means a transaction or transmittal on behalf of an individual who places an unlawful drug importation request to any person engaged in the operation of a registered foreign pharmacy.

Now we have got to know who the registered and unregistered ones are and whether it is lawful or unlawful drugs. Again, there is so much literacy that has to go into this, as opposed to what you get in the United States, that you know it was from the United States.

We probably do pay a premium for our safety. Most people want to be sure they are safe. There is also a little bit of a problem with the bill the way it is written and being able to tell about the wholesale licensure and the pedigrees that go with that licensure. There will be another amendment that will be submitted that hopefully can clear up some of those problems. I hope people will work with us.

As you can see, one of the things we are trying to do is to make a problem better. I think it would have been a lot better if we could have gone ahead and had the drug safety taken care of today, which we were on a track to do, because Senator Kennedy and I had already worked through all of the amendments that had been turned in, with the exception of the importation one. We had been able to resolve or have them withdrawn for almost everything and could have wrapped it up with a few more votes. But it will take us a little longer now. We are hoping there are opportunities to improve the bill. I know under the procedure of the Senate there are ways to keep people from being able to have votes.

I mentioned a number of times the success Senator Kennedy and I have

had with the Health, Education, Labor, and Pension Committee, a big bite of the apple, the success we have had in the previous 2 years. Some was because we did not follow an exact procedure of going to a markup and arguing until things were polarized. We took what we could and worked with people through the process, and they trusted us enough to work through the process, so by the time it came to the floor, we had a managers' amendment that covered a lot of the difficulties people had with the bill.

When you put in an amendment, technically the amendment is one way or the other. Oh, yes, there are ways to do second-degree amendments, but you will not see many of those around here, because that is putting in another very concise set of words that is accepted or rejected. They can change the original bill a little, or perhaps a lot. Some of them can be complete substitutes. But they are polarizing, and they do not take care of the technicalities. The advantage of running the bill through this sized body, then through the other end of the building with 435 people, is to get 535 opinions of what ought to be done. Out of 535 opinions, we can usually come up with a pretty good bill. But when an amendment is put in and there is no way to do any correcting, or the only way you can do correcting is another take-it-or-leave-it bill correction to it, it is a very difficult way to get any legislation done.

Our success over the last 2 years of getting legislation done was because we worked this process of continually working until we got to a final product, which meant cleared through conference committee.

But evidently we are not going to do that this year with this piece. It was a significant victory for someone who has worked very hard on it. Senator Dorgan has worked hard on it for a long time. He did an outstanding job of presenting it. Now I am hoping he will work to see that it gets perfected a little bit more. It cannot be perfected in the way we normally perfect it, but a little bit more as we go through the process, and perhaps by about next Thursday we can finish with the bill. It is an extra week of work, but I think this could have been brought up in a separate bill, handled individually, and had some of the same mechanisms for improving it we would normally have in a bill. But that is behind us now. So we continue to work on the bill, and we hope by a week from today we can have this concluded.

Mr. President, I yield the floor, and suggest the absence of a quorum.

Mr. President, if I could ask the ranking member for a few minutes to speak about reimportation.

Mr. President, I thank the ranking member.

I find it somewhat ironic that we are on the floor to discuss an amendment to a drug safety bill which would allow drugs to be imported freely from any country around the world. Maybe I am the only one who finds some irony in that. We are constructing a mechanism in this country to set up a system of surveillance, to recognize red flags that may suggest to us we need to look deeper into the unintended consequences of drugs that have already been proven safe and effective; and we go even further than that and codify into law a very regimented process for the Food and Drug Administration to go through if, in fact, it is triggered that there might be a problem. Then, in the same bill, because of the outrage over the concerns we have for prescription drugs, now we are going to say to the Chinese: continue to manufacture, continue to ship in, and these products may not even have an active ingredient.

We adopted Senator Durbin's amendment that related to pet food safety standards. Well, what this suggests to me is that for us to consider the importation or reimportation of drugs is to say we put pet food above the drug chain for the American people, that we are willing to put more standards on pet food today than we are on the importation of these drugs.

Passage of the Medicare prescription Part D plan, which was a year ago, lowered significantly the pressure that was felt to obtain drugs over the Internet or drugs from other countries. Why? Because in the first year, we have seen a 33-percent reduction in the price of those pharmaceuticals for our Medicare-eligible population. It is not that all the pressure is off, but I am not sure the remaining pressure is going to be alleviated by providing a drug supply that has no active ingredient or that denies consumers the security of knowing they are going home and they are taking their drugs but then they suffer the consequences of ending up in an emergency room because they didn't get the active ingredient they needed.

Last year, 1.7 million tablets of counterfeit Viagra were uncovered; 1 million tablets of Lipitor that were, in fact, counterfeit; and a half a million tablets of Norvasc were seized in China.

What is unfortunate is China is not the only country in the world where we have created a cottage industry of producing drugs that look just like the ones we sell in a pharmacy but that we regulate at a gold standard that many on this floor have tried to protect every time we debate legislation that is about the Food and Drug Administration. We are here today to assure the American people that we are raising the gold standard--that it is not just the bar of where we determine safety and efficacy but we are raising the standard when the population at large is exposed to that medication to make sure that, in fact, unintended consequences are fully investigated. To accept the importation of foreign drugs is to open the door for a cottage industry today to become a mega industry tomorrow by supplying counterfeit drugs with no active ingredient, with the potential that there are ingredients in it that are adulterated, that will not only not solve the health problems but, as has been proven in the pet food supply, could kill. Now, when people die, we put the standards higher than we do the standards of reimportation or importation of drugs. I urge my colleagues to at least accept the Cochran amendment which puts a safety standard in, but do not pass this importation legislation.

Mr. President, I agree with my colleague that this issue has been around for a long time. One of the reasons we continue to debate it is because we continue to have real-life examples of a product that comes in that is adulterated. I am not sure we have done anything to eliminate the ability to counterfeit, other than to confuse it even more, because, in fact, today we basically say it is almost impossible, unless you are an individual crossing the border, to bring in drugs from another country.

We are challenged at Customs today with immigration. Oh, we are just as challenged at Customs today on the shipment of pharmaceutical products that come into this country from abroad. It is not held to a single country.

I do not believe the reason we embrace this bill is because the Europeans do it. There are a lot of things the Europeans do today that I would not necessarily suggest are right for America. As a matter of fact, we have some international treaties that suggest we should harmonize our drug standards with the European Union. What we found was, for the European Union, with 22 members, they accept whichever country the application was applied for. If that country approves it, then it is good for the EU. If you look at some of the standards throughout the 22 countries, it would be dismantling the gold standard of the FDA.

So for those who suggest what we would do in this amendment maintains our gold standard, it would not happen. The reality is, as you accept what they do--which does not come close to the gold standard of the FDA for safety and efficacy--over time it would bring further deterioration to the confidence of our drug supply. When every American goes to their local pharmacy and they have their prescription that is written by a doctor, they go in with 100 percent confidence of knowing there is an active ingredient in it, that it is not adulterated, that their health is not going to be affected adversely when they take it.

We are on the floor today. This is part of the drug safety bill. Why? Because in some cases when products are approved and given to a much larger population, that larger population experiences different side effects because every person is genetically different. There are no two alike, unless we change the cloning laws in this country. The reality is, I do not think we are going to do that, so we do not have it to worry about. But we are here trying to strengthen the safety of the product. We currently can maintain the chain of custody because it is manufactured, it is distributed, and every product has a case lot number.

What have we experienced with counterfeit drugs? They have been able to make a pill look identical to the pills we go to the pharmacy and buy--identical in not just the pill but the packaging. As we shift packaging, so do those who are trying to game the system. The reality is, the person who is on the receiving end--and I sympathize with exactly what the Senator from North Dakota has claimed; that in many cases, pharmaceuticals are not affordable for some people. That is why we created Part D Medicare. That is why over 30 million Americans who are Medicare eligible now have coverage--coverage that has brought down the price of pharmaceuticals 33 percent in the first year.

For any other area for which we would propose legislation, if we saw a trend like this, we would be embracing the fix we put in. But no, we are going to delude it even further and confuse seniors across the country and say: Now just go on the Internet and buy it because we have said it can only come in if it is an FDA-approved product. Well, FDA- approved products are the only things we write prescriptions for in the country. The reality is, the only counterfeit product that counterfeiters are making are FDA look-alikes.

There is nothing in the Dorgan bill that says somebody cannot counterfeit anymore. There is nothing in the bill that says if we do not catch it at Dulles Airport when it flies in and test it immediately to find there is no active ingredient, we have not put somebody's life in danger. There is no assurance in this bill that if there is an adulteration of some kind that affects somebody's health--in the host of millions of pills that come in, if we do not catch it, there is somebody on the receiving end who is going to be adversely affected health-wise.

So I appreciate the fact that everybody wants cheaper drugs. We all do. But there is a reality about the United States of America: We protect intellectual property; therefore, we attract companies. And it is not just limited to pharmaceuticals. I guess the next thing we are going to do is claim Microsoft software is too expensive, so we are now going to allow that to come in from somewhere else. Well, we protect handbags. We protect clothing. We protect the copyrights, the intellectual property. There is even more of a reason to do it in pharmaceuticals. It is because there is a safety component.

I think when many people think they might be buying a counterfeit handbag--if they buy it on the streets of this town or some other town--they probably think: Well, if I get a year's use out of it, based on the price, that is OK. I do not think you can apply the same standard to pharmaceuticals. If it does not have the active ingredient, somebody might die. In fact, we beefed up, in the drug safety bill, dog food higher than what this importation provides for our pharmaceutical supply in this country.

We are going to have plenty of time to talk about it. And just as the Senator from North Dakota brings a lot of facts and figures to the floor, there are a lot of facts and figures from the 8 years--maybe more--we have debated this issue. It has not been Congress that has turned it down, it has been the American people. At the end of the day, they send us here to make decisions that are positive in relation to their health and their future. I do not think Americans want to take a pig in a poke on pharmaceuticals. But that is what this amendment will allow to happen.

This will probably change America being the innovator of drugs and medical devices because we will ignore patents and copyrights. We are advantaged by that. There are many countries in the world where you do not have access to the drugs and biologics and devices we have in this country. Yes, they are expensive because they are expensive to develop, but we put more value on quality of life, the ability for us in this country to treat what others are not able to treat because we believe that, in the overall scheme of our system, we save more money in health care if, in fact, we give somebody a pill. If that was not the case, we would not have programs for HIV/AIDS. But every time we supply that

therapeutic for an HIV/AIDS patient, we know they are not going to have one case a year with some type of retinal infection. We know they are not going to be admitted to the hospital for a week because of pneumonia. We know the savings over that incident is probably going to be $15,000 or $20,000, and that is before we put any cost on the quality of life of the patient who is affected by the disease.

Well, I would imagine we will see counterfeit HIV products because they are expensive. It is one of those diseases that does not stay in the same place. It is smart. It changes itself within somebody's body, and it means that over a period of time, you can take a drug that is very effective or a combination of drugs that is very effective, and after 2 or 2\1/2\ or 3 years, the disease has now changed, and if you do not change with new therapies, the reality is there is going to be a deterioration of that person's quality of life and a further advance of the disease.

Right now, we have companies that are excited about working on the next product that will continue to take a disease we cannot cure today but for which we can stop the progression right in its tracks. What we are going to say to those companies that spend hundreds of millions of dollars, if not billions of dollars, is: Well, the United States does not put any value on that anymore. Say that to the population that is affected by the disease. Say that to the population of any group of Americans that is affected by a disease, that we are not going to have the policies in place that advance the development of drugs, biologics, and devices. When we do this, that is what we are saying.

Again, I appreciate the authors' attempts to try to assure us that safety is at the forefront. But that is only there if we are smart enough to catch it. If we were that smart, we would not have an illegal immigration problem in this country. If we were that smart, we would know that we caught 100 percent of what was coming in the country. But I do not think there is anybody who is going to take this floor and suggest to the American people that we catch 100 percent of the adulterated or counterfeit drugs. There is certainly nobody who can come to the floor, even with our food safety standards where they are-- where the FDA is in charge and USDA is in charge and DHS now has some responsibility for it--and suggest to the American people that we catch 100 percent of the contaminated food before it finds its way to the shelf or to a plate in our house.

The reality is, we have had 12 examples just in the last year where we are just not that good. We are not perfect. I would suggest to you, to try the system, by setting up a program that cannot be policed--and I think that is what my colleague from Mississippi was saying. Time and time again, we have had the debate. We have pulled in the experts. They have said this is just something which is undoable for us. We cannot do it.

My hope is that as this debate goes on, more and more Members will realize it sounds good, but it is not a risk we should take in this country. It is a risk that affects people's lives.

I yield the floor.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, we are at a lull in the movement of the drug safety bill, a bill to assure American consumers, American patients, that there is more than just the acknowledgment by the Food and Drug Administration that a drug is safe and effective; that there is a mechanism post-approval as Americans across the country begin to take those medications; that we are watching for potentially any adverse reactions to a drug that a new population, an increased number of Americans that may be taking the drug. It is in an effort to make sure that if we see the signals of that unintended consequence, that we look more thoroughly at the benefits of that drug being on the market.

When I left the floor earlier today, the sponsor of the importation amendment suggested that Vioxx was not beneficial to anybody. The fact is, I do not think it is the role of Members of the Senate--unless you are Dr. Coburn--to suggest that you practice medicine. There are physicians who found the advantages of Vioxx, while it was on the market, they found it was advantageous to thousands, if not hundreds of thousands, of patients.

I am sure those patients are back on ibuprofen, Naprosyn, or other products that might cause significant gastro challenges for them, and that is why their doctors switched them originally. They needed relief from pain.

Well, a lot of things have been said, and the Senator from North Dakota said we should stay focused on the facts. I have come to the floor for a few minutes just to talk about some of the facts.

Many of us have suggested that, two years ago, when we created Medicare Part D--which is a prescription drug benefit for individuals in this country who are Medicare eligible--we lessened the problem that many seniors had expressed; and that is, their inability to buy pharmaceutical products.

Just recently, an analysis published by AARP, the American Association of Retired Persons, showed the new Medicare drug benefit saves seniors more money than buying pharmaceuticals from Canada. Now there is a new one. For those who are on border States, the AARP--the authority because they certainly had a loud voice before Part D was created--said drugs from Canada are actually more expensive than what Part D has been able to negotiate.

Let me say in every State we have multiple choices. Seniors make their choice. They participate in a plan. It is a private sector plan. But there are basically four large benefit managers, and they negotiate prices. What they have done is, they have been able to negotiate a price that has even exceeded what Canada could sell drugs for at retail.

This AARP bulletin found that many who choose the least expensive plan that meets their prescription drug needs--this is under Part D-- will still pay less for those drugs than they would purchasing them from Canada. So it is not the ``Cadillac'' plan that seniors would have to choose to get less expensive drugs in the United States than from Canada. In fact, with the least expensive plan, AARP evaluated they would get a cheaper price on their pharmaceuticals by having Part D, accessing it at a U.S. pharmacy where they can feel fairly confident, if not totally confident, the product is, in fact, what they thought it was.

Just recently, in Detroit, MI, an indictment charging 19 individuals with operating a global racketeering conspiracy, was unsealed. The Federal court announced--the U.S. attorney for the Eastern District of Michigan--the indictment alleges that portions of the profits made from illegal enterprises were, in fact, funding Hezbollah. This is a foreign terrorist organization, by the way. Nine of the individuals were arrested. The indictment charged that between 1996 and 2004, this group worked together in a criminal enterprise to traffic in contraband cigarettes, counterfeit Zig-Zag rolling papers, and counterfeit Viagra.

So as to the claims we have made on the Senate floor--I believe the Senator from North Dakota when he says: We have done everything we can in this bill to assure the public of the safety and integrity of the product--though there is nothing in the bill that forbids anybody who wants to circumvent the law, in other words, make counterfeit drugs, make drugs that have no active ingredient, make drugs that look just like those drugs that are approved by the FDA, whether they are Viagra or Zocor, and to find a way for those to come to the marketplace.

It is not something the FDA today, or any FDA prior, has said they can police. For those Members who have been intricately involved since September 11, 2001, at understanding what our ability is to have a full knowledge of what comes into this country, some of us have actually gone to Washington Dulles Airport. We have seen the Customs officials go through the bags and bags of pharmaceutical products that come into this country. It is impossible, without a chemical test, to determine whether one tablet is authentic or the next one is counterfeit, whether one has an active ingredient or whether one is minus all active ingredients.

There have been several operations conducted in this country that deal with the cyber-trafficking of pharmaceutical products.

Fictitious pharmacies: These are companies that prey on individuals who are solely looking for low-priced pharmaceuticals. They think they are dealing with reputable pharmacies around the world. Yet there is no pharmacy. At the other end of the Internet are crooks. They prey on people who look for pricing. In fact, as some of those groups have been rolled up by our law enforcement, what we find is the products that were coming in had substantial deficiencies in things such as active ingredients.

What happens when a patient takes a product where the active ingredient does not exist? The illness they have is not affected. For an individual who might have high cholesterol who has been put on a drug that will lower that cholesterol because they are susceptible to heart problems, to have no active ingredient means they have a cholesterol buildup in their veins, and without intervention the likelihood is they might have a heart attack. They might die. Unfortunately, when they take a drug they think is real, but it has no active ingredient, unfortunately, they do not know until they have a medical incident.

So let me make this point to all my colleagues: If the purpose is to lower the cost of health care, then we are taking a mighty big risk because, in fact, what we may be doing is we may be raising the cost of health care in America, and with a disregard for the lives of the individuals who might be affected.

When I came to the floor earlier today, I mentioned that last year alone 1.7 million tablets of counterfeit Viagra were uncovered, 1 million tablets of Lipitor. This is according to the Wall Street Journal. I think that is surpassed, though, by the fact that last year--as we were in the heat of this new potential pandemic flu, H5N1, the bird flu; and we aggressively in this country then and still today are trying to come up with a vaccine and with

other countermeasures that might be able to defeat or minimize the impact of the bird flu--companies around the world started to look for Tamiflu as a successful countermeasure.

Individuals in this country searched outside of the country

because the supply was so limited. Well, Customs agents have

intercepted more than 50 shipments of counterfeit Tamiflu. It

is an antiviral drug that is specifically designed to be

stockpiled for the pandemic flu.

You see, my point is this: Counterfeiting, the trafficking of pharmaceuticals exists today. Anything that loosens the regulations on access to these pharmaceuticals invites more people to participate in gaming the U.S. consumer and, for that matter, the global patient. This is not something that is limited to the United States.

Clearly, the adulterated product is usually a product that

is manufactured somewhere outside of this country. Not only

can they make a handbag look like a designer bag, they can

make a ``Viagra'' pill look like Viagra. Now, unfortunately,

you will know real quick whether there is an active

ingredient in that. But you will not know if it is, in fact,

a cholesterol-lowering drug or one of the things that really

does affect the long-term health of the American people.

A study published in the medical journal Science found when a cholesterol-lowering drug manufactured in the United States was compared just to generic copies bought over the Internet from Mexico, Thailand, India, and Brazil, there were differences in the blend, the uniformity of the blend--an error that could dilute their effect on patients. The authors concluded that clinically this would have significance for a patient who was prescribed a half a tablet per day, which is not an uncommon practice.

So for that senior at home, who has suggested an increase in the amount of milligrams of active ingredients so they can cut their pills--take half one day and half the next day because there are ways to maximize--what this report found, published in the medical journal Science, was that an adulterated product that does not reach the correct consistency throughout the pill might on one side provide the active ingredient and might on the other side not provide any active ingredient whatsoever. It could affect the dissolving rate, which could affect the onset of effect, or bioavailability.

These are stories that come right out of medical journals. This is not about pharmaceutical companies and how powerful they are in Washington. This is about whether the focus of the Senate is on the safety and the well-being of the American people. This is about whether, in fact, we are going to maintain the gold standard of the Food and Drug Administration or whether we are going to accept the standards of other countries in the world where their bar is not quite as high, where they are willing to accept less in innovation, just to receive less in price.

I am not sure that is a good tradeoff for the country. Clearly, the Senator from North Dakota has the votes potentially to win this. I do not find that too comforting, myself. I spent 2 years of my life actively involved in the 1997 modernization of the Food and Drug Administration. I worked with people on the right, the left, and the middle. I worked with people who wanted to do things at the FDA that today we still have not done, thank goodness, but there are still people who want to do it. But we all came together to uphold one thing in that process--not to lower the bar, not to lower the standard that we asked companies to reach with their products for us to put that FDA stamp of approval, ``safe and effective,'' on it.

There are products sold outside the United States that could never pass the application process in this country. I know the Senator from North Dakota does not, in his bill, allow those products to come in. He limits it to FDA-approved products. So my focus is solely on the product that is FDA-approved in this country, but that has been manufactured in a way that either provides little active ingredient or no active ingredient, and with potentially harmful components found in that pill, or whatever the dosage might be.

It is my hope we will continue to talk about this issue. But when I left the floor I thought it was important to go look at some of the articles to see if this is still a real problem. It is a problem today. It will be a problem tomorrow, and if we pass this, I think it will be a bigger problem in the future. It is a problem that is involved in funding terrorism around the world. It is a problem that will not go away, but at least today, we are able to control it. We are able to control it in a way that has a smaller effect on the quality of life of the people in this country. I think that is why they have us here. But we will continue the debate and we will see where we end. I think it is important enough that we spend days, if it takes days, to debate this legislation and to make sure everybody in this country understands what is at stake.

I yield the floor.

Mr. President, I congratulate my colleague from North Dakota for the extraordinary and comprehensive outline of this issue that he has made not only today but in the past.

Mr. President, every single day in this Congress, and throughout America, people sit down and eat their lettuce and tomato and their salads. Their tomatoes come from Mexico, Latin America, and their lettuce comes from Latin America. Other foods they eat come from as far away as China. Billions of dollars of food imports come into this country, but I don't hear anybody in this body standing up and saying, oh, we have a problem about food safety or food coming from other countries. They come in.

There is a problem--and I don't hear it too often here, but somehow the U.S. Government, with the FDA, cannot regulate a small number of drug companies so that we can safely bring in prescription drugs from Canada and other industrialized countries so that, as a result, we can substantially lower the cost of medicine for millions and millions of Americans. This is absurd. Of course, we can safely regulate the flow of medicine coming into this country.

The real issue is not the safety of medicine. The real issue is the power of the pharmaceutical industry, the most powerful industry in terms of lobbying impact in the United States of America. If you think the oil companies are powerful, take a look at the drug companies. If you think the banks are powerful, take a look at the drug companies. Today, we are living under a Medicare Part D prescription drug program that was written by the drug companies, for the drug companies. Today, billions of dollars of taxpayer money goes into research and development for new medicines that go to benefit the drug companies, while the American people do not get reasonable prices for the products they help to produce.

Mr. President, since 1998, the pharmaceutical industry has spent over $900 million on lobbying activity--$900 million. That is more than any other industry. Today, there are over 1,200 prescription drug lobbyists right here on Capitol Hill and throughout this country. Do you know what their job is? Their job is to make sure in the United States of America we continue to pay, by far, the highest prices in the world for the medicine we use.

If you have a chronic illness, there is a strong likelihood you will be paying two times as much for the same medicine as our friends in Canada or Europe pay. Why is it that the same medicine, manufactured in the same factory, costs us, in some cases two times, and in some cases three times, as much money as it costs our Canadian and European friends?

The answer is pretty simple. It has everything to do with the power of the pharmaceutical industry and the enormous amounts of money they spend on lobbying, on campaign contributions, on advertising, and the pressure they put on Members of the United States Congress.

Mr. President, I have been involved in this issue for a number of years. I have been involved in it in an emotional way because I was the first Member of Congress to take constituents over the Canadian border to purchase, in that case Tamoxifen, which is a widely prescribed breast cancer drug that ended up costing Vermont women one-tenth the price they had to pay in the United States.

In our country today, there are people struggling very hard with terrible illnesses who have no health insurance and who need their prescription drugs. Some of them simply cannot purchase their prescription drugs. Some are taking money out of their food budget to buy their prescription drugs. We are a great nation in many respects. But the time is long overdue for Members of the Senate, for Members of the House, to reclaim this institution from the powerful special interests.

Today is a day of reckoning. This is very important legislation. This can drive the price of prescription drugs down by 25 to 50 percent. Let's stand together and, for those Members who are wavering on the issue, who think they cannot vote for it, I hope at least they will support cloture to allow us to continue this debate and to finally lower the cost of prescription drugs for the American people.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I rise in strong opposition to the Cochran amendment. We should be very clear. For anybody who is interested in prescription drug reimportation, for anybody who is interested in lowering the cost of prescription drugs in this country from 25 to 50 percent, for anybody who is interested in standing up for the working families of this country who are getting ripped off every day by outrageously high prescription drug costs, the Cochran amendment is a poison pill. To vote for the Cochran amendment is to vote against prescription drug reimportation; it is to kill the Dorgan amendment.

The idea of asking permission from the Secretary of Health and Human Services, from the Bush administration, who have already gone on record rather firmly and decisively in opposition to reimportation, is to simply mask your vote. The Bush administration represents the pharmaceutical industry. They will kill prescription drug reimportation. To ask their permission to go forward is simply to kill prescription drug reimportation. So anyone who is serious about lowering the cost of prescription drugs will not be supporting the Cochran amendment.

The unfortunate reality is, in the United States of America we continue to pay, by far--it is not even close--the highest prices in the world for prescription drugs. Because of the escalating cost of medicines, many of our fellow Americans, many working people, many people with chronic health problems, simply do not get their prescriptions filled. I am sure in Montana the experience is the same as it is in Vermont. People tell me they walk into the drugstore and cannot believe

the prices they are being charged. They can't afford those prices. I have talked to pharmacists, as I suspect the Chair has as well, who have been embarrassed. They have seen tears coming out of people's eyes when they have told them the cost of their medicine.

Meanwhile, as a result of the power of the pharmaceutical industry, we have the highest prices in the world, and those prices are rising every single day. In fact, tomorrow, if an American walks into a pharmacy and the pharmacist says to that person: I am sorry to have to tell you this, but the cost of your medicine went up 50 percent, or 75 percent, we can do nothing about it. Unlike the rest of the industrialized world--Canada, Europe--where they understand prescription drugs are an integral part of a whole strategy regarding health care, we let the drug companies do anything they want to do.

As the first Member of Congress to take constituents across the Canadian border to enable them to pay substantially lower prices than they were paying in the United States, I have seen firsthand what it means to people's lives when they get the drugs they need at a price they can afford. I will never forget--never forget--when in 1999 I brought a busload of Vermonters over the Canadian border. Many of the women there were struggling with breast cancer, fighting for their lives, and they didn't have a whole lot of money. They went to Montreal and purchased Tamoxifen, a widely prescribed breast cancer drug, which at that time--at that time--was one-tenth the price they were paying in the United States. Imagine that. Fighting for your life, not having a lot of money, and needing a drug. Suddenly, they looked at the price they were paying and they literally could not believe it.

Mr. President, I ask unanimous consent that a chart which compares prices in the year 2005--so the prices may be different today, but as of April 2005, a price comparison between United States prices and Canadian prices, and United States prices and German prices.

Mr. President, let me talk about a few of the drugs.

Actos is a drug for diabetes. As of 2005, in the United States, the price of that drug was $116. For the same number of pills and the same milligrams, it was $50.62 in Germany. Twice the price--same product, same company, same factory, but less than half the price in Germany.

For Celexa, a drug for depression, it was $85 in the United States and $35 in Germany. Same company, same product. Clarinex was $77 in the United States and $38 in Germany. On and on it goes--sometimes more, sometimes less but often half the price in Germany, and different prices in Canada but often the same end result.

The very simple question the Members of the Senate have to ask themselves is: Why is it that in the United States we have to pay the highest prices in the world for our medicine? Why is it that at a moment in history when we are eating food products from farms in Mexico and in Latin America, produced in China, and they are coming to our kitchen tables today, why is it that anybody here can say with a straight face it is OK for products all over the world to come into this country from tens of thousands of farms, but in terms of a handful of major drug companies, somehow we cannot regulate the flow of those medicines from Canada, for goodness' sake, into the United States?

Give me a break. That argument is so totally absurd as to be almost beyond the laugh test. This debate has nothing to do with drug safety. All of us are concerned about drug safety, and the Dorgan amendment has page after page after page of regulations making sure the FDA-approved medicines that come into our country will be safe.

What saddens me very much is that in many ways the American people have given up on this issue in terms of the ability of their own government to act, and they have taken matters into their own hands. I don't know what goes on in Montana, but in the State of Vermont thousands of people in our State go over the Canadian border. They go to the Canadian drugstores and buy the products they need. It is not a big deal, and they save substantial sums of money.

There was an estimate a few years ago, and I don't know what those numbers are today, but there was an estimate several years ago that about 2 million Americans were buying their medicine in Canada. What the Dorgan amendment is about is simply saying that it is a little bit absurd for Americans to have to get in their cars and drive to Canada to get the drugs they need; that it might make more sense for our pharmacists to be able to purchase that medicine, our prescription drug distributors to be able to purchase that medicine so, in fact, Americans could take advantage of the lower prices at their own local drugstore.

That is what we want to do. We don't want all of America to have to go to Canada or Germany to buy reasonably priced medicine. We want those products sold in this country at an affordable price.

I think many Americans are wondering: Well, how does it happen that a product made by an American drug

company--at a time when the taxpayers of this country, by the way, spend billions of dollars in research and development for drugs that go to the drug companies--that in the midst of all this, how does it happen that we pay two or three times as much as our neighbors in Canada or our friends in Germany or throughout Europe? How does that happen?

Well, the answer is pretty simple. The answer is pretty simple. The answer has everything to do with the way we do politics in this country and the enormous power of large multinational corporations and the enormous power of lobbyists who represent those corporations. Let me quote from a Washington Post article of Friday, January 12, 2007. It is a front page article. This is what it says. This is January 12, 2007:

This month alone [i.e. January] the Pharmaceutical Research

and Manufacturers of America [PhRMA] spent more than $1

million on full-page newspaper ads touting the success of the

existing Medicare drug system.

Drug companies spent more on lobbying than any other

industry between 1998 and 2005--$900 million, according to

the nonpartisan Center for Responsive Politics. They donated

a total of $89.9 million in the same period to Federal

candidates and party committees, nearly three-quarters of it

to Republicans.

``You can hardly swing a cat by the tail in Washington

without hitting a pharmaceutical lobbyist,'' said Senator

Charles E. Grassley, Republican of Iowa, a key sponsor of the

2003 legislation that created the current program.

That is what we are dealing with today, and we should not kid ourselves. The pharmaceutical industry, year after year, turns out to be one of the more financially successful industries in our country. According to Fortune magazine, the top 19 pharmaceutical companies in 2005 made $42.1 billion in profit; in 2004 the profit margin was almost 16 percent, three times higher than the average Fortune 500 company.

That is what you have. We have a situation where millions of Americans are struggling to pay their prescription drug costs. We have a situation where many Americans simply cannot afford the medicine they desperately need. We have a pharmaceutical industry which, year after year, enjoys some of the highest profits of any industry in this country. We have an industry which pays its CEOs very exorbitant salaries. We have an industry which has an estimated 1,200 paid lobbyists in this country, many of them former leaders of the Republican and Democratic Parties. We have an industry that makes huge amounts of campaign contributions. We end up with a situation in which we pay by far the highest prices in the world for prescription drugs.

Senator Dorgan quoted a study from the CBO, I believe it was, that suggests we could save some $50 billion over a 5-year period if we move to prescription drug reimportation. In this body we have people who get up every day and tell us how wonderful they perceive unfettered free trade to be. It is not a problem when American workers are thrown out on the street because factories are moved to China where people are paid 30 cents an hour; hey, that is part of the global economy. No problem there. There is no problem when food comes into this country from China and our farmers lose money. No problem. That is part of the global economy.

But somehow, amazingly enough, when an aspect of free trade works for the average American and not for a large multinational corporation, suddenly we do not like unfettered free trade. Suddenly we cannot reimport prescription drugs from Canada--from Canada, which neighbors us, obviously--from a handful of drug companies. We cannot do that. I think that argument is very absurd.

Let me conclude. A vote for the Cochran amendment is a vote to kill prescription drug reimportation, pure and simple. The Bush administration has said they will not go forward with reimportation. Let us defeat the Cochran amendment. Let us pass the Dorgan amendment. Let us lower prescription drug costs in this country by 25 percent to 50 percent. Perhaps even more important, let us show the American people that the Congress has the courage to stand up to the most wealthy and powerful lobby on Capitol Hill.

I yield the floor.

I suggest the absence of a quorum.

Mr. President, the debate we are now having is an extraordinarily important debate; in fact, it will be one of the most important votes we will be casting this year.

This vote is about whether we stand with the American people, millions of whom are having a very difficult time paying their prescription drug bills or whether we stand with the most powerful and greedy lobby on Capitol Hill, and that is the pharmaceutical industry which has spent extraordinary sums of money to make sure the American people pay outrageously high prices for the medicine they desperately need.

I wish to briefly examine a chart which talks about the very high profit margin of the pharmaceutical industry. One of the reasons why the pharmaceutical industry can spend so much money on lobbying, on campaign contributions, on advertising is because of the profits they make year after year.

In 2004, drug companies ranked as the third most profitable industry in the United States with a 15.8-percent profit margin, which is about three times higher than the profitability of a median Fortune 500 company, which is at about 5.3 percent. This is in 2004. This comes from the Kaiser Foundation.

What we can also see, and what this chart tells us, is the extraordinary profits the drug companies are making from particular drugs. Epogen is the drug. Amgen is the company with profits of $2.5 billion. Taxol is the drug; the firm is Bristol-Myers Squibb, $2.1 billion for one drug, and on it goes. They are profitable year after year. The pharmaceutical industry continues to be one of the most profitable industries in this country.

I have another chart. One of the issues I look forward to discussing with Members of the Senate is the fact that as taxpayers in our country, we contribute billions and billions of dollars to the National Institutes of Health, the universities, the foundations for the very noble and important purpose all of us support: to create drugs that will address the major illnesses facing us, whether it is cancer, diabetes, AIDS, whatever it may be. We have spent billions and billions of taxpayers' dollars in a sense subsidizing the drug companies and, in fact, taxpayers do not get any reasonable price returns from them. We just give them the money.

Here is an example. Taxol is a very important and widely used medicine. According to a 2003 GAO report, the NIH spent $484 million on research for Taxol, Bristol-Myers Squibb spent $1 billion and subsequently earned $9 billion in profits.

In other words, American taxpayers are paying twice: once in the form of underwriting pharmaceutical research and the second time in the form of monopoly prices.

When we talk about the drug companies, we should also deal with the issue they often bring up. PhRMA is a very powerful lobbying group, the most powerful trade group on Capitol Hill. What they tell us is they need these very

high prices, they need all of the taxpayers' money because they are putting all of that into research and development. Don't we all want new drugs for diabetes, cancer, AIDS, and a dozen other terrible illnesses? This chart tells us something a little bit different.

This chart tells us the pharmaceutical industry spends far more for marketing--and goodness knows we have seen their ads on television over and over again, and guess who is paying for those ads. We are, in terms of high prices for the drugs, far more for marketing than for research and development.

Let me get back to the thrust of what this debate is all about, and let me be very clear. As I mentioned a little while ago, the Cochran amendment is a poison pill. If anyone is serious about prescription drug reimportation, if people are serious about lowering the cost of prescription drugs from 25 to 50 percent, if people are serious about standing up for consumers in this country, they will vote against the Cochran amendment.

So that no Senator has any doubt about what is going on, Mr. President, I ask unanimous consent to have printed in the Record a Statement of Administration Policy, dated May 1, 2007, from the President's office, and I will quote from the bottom of page 2, where there it is in black and white. This is a two-page letter. It says:

As a result, if any such importation provision were

included in the final version of the bill presented to the

President, the President's senior advisers would recommend

that he veto the bill.

Mr. President, the first flaw Secretary Shalala identified was the lack of any requirement that the drug manufacturers give importers permission to use the FDA-approved labeling for imported medicines.

The Dorgan amendment addresses that concern.

The second flaw identified by Secretary Shalala was the lack of any ban on drug companies discriminating against foreign companies that export medicines to the United States.

The Dorgan amendment addresses that concern.

The third flaw identified by Secretary Shalala was the 5-year sunset in that version of the bill. That sunset would limit the public benefit from the investment the public would be making to put a safe reimportation system in place. In other words, she was saying, why should we go through all this effort if we are to only have a 5-year process.

The Dorgan amendment addresses that concern.

Finally, the Secretary noted the absence of a long-term income stream to fund enforcement of the reimportation system.

The Dorgan amendment addresses that concern.

In short, to characterize Secretary Shalala's letter as one that says reimportation is unsafe is to mischaracterize the essence of that letter. What Secretary Shalala was critical of was poison pills, what she called ``flaws and loopholes'' that were put in, or allowed to remain in the bill at the bidding of the pharmaceutical industry so they could defeat reimportation.

I have been involved in this issue for a long time, and that is what the drug companies do. Every day there is another reason why we can't go forward to lower the cost of prescription drugs. Every day there is another reason why we have to pay the highest prices in the world for prescription drugs. We have 1,200 lobbyists, no doubt many of them running around right now knocking on doors, to make sure our people continue to pay the highest prices in the world.

Secretary Shalala wrote in her letter that she, in fact, hoped Congress would fix the flaws and close the loopholes in that 2000 legislation of 7 years ago, and this is what she wrote to President Clinton:

Mr. President, the changes to the reimportation legislation

that we have proposed can and should be enacted by the

Congress next year.

In other words, in 2001. Let me repeat that. Secretary Shalala wrote to President Clinton:

Mr. President, the changes to the reimportation legislation

that we have proposed can and should be enacted by the

Congress next year.

Unfortunately, it has taken 7 years of work to bring us to where we are today. This should have been done years ago. Under the Republican leadership, there was no question we could not get to first base on reimportation. I hope things have changed now.

Let me conclude by saying that anyone who comes up here and says they are for reimportation but they are voting for the Cochran amendment is in fact not for reimportation. Anybody who comes up here and says, well, even the Clinton administration said we could not do that, I am afraid also that is not accurate and I think they are quoting Secretary Shalala, who was then Secretary of Health and Human Services, out of context.

As I have mentioned before, I have been through these battles with the

drug companies before. There is nothing the pharmaceutical industry will not do--nothing--in order to make sure they remain one of the most profitable industries in America. They will say anything, do anything, and put any kind of pressure they can on Members of the Senate or Members of the House.

Today, we have an opportunity to do something important. For many years there was growing concern in this country about a do-nothing Congress, about a Congress that was worried far more about the wealthy and the powerful than the needs of ordinary Americans. The elections in November have changed that. We have new leadership here. I hope very much that under this new leadership we will all summon up the courage to stand up to the drug companies, the most powerful, the most greedy lobby and industry right here on Capitol Hill, and that we will go forward and we will pass this legislation to lower the cost of prescription drugs for all Americans.

Mr. President, I yield the floor, and I suggest the absence of a quorum.

Mr. President, I rise today with the senior Senator from Hawaii to introduce the Native Hawaiian Government Reorganization Act of 2007. This bill, which is of great importance to the people of Hawaii, establishes a process to extend the Federal policy of self- governance and self-determination to Hawaii's indigenous people. The bill provides parity in Federal policies that empower our country's other indigenous people--merican Indians and Alaska Natives--to participate in a government-to-government relationship with the United States.

January 17, 2007, commemorates the 114th anniversary of Hawaii's beloved Queen Liliuokalani being deposed. Although this event may seem like a distant memory, it is a poignant event that expedited the decline of a proud and self-governing people. The overthrow facilitated Native Hawaiians being disenfranchised from not only their culture and land, but from their way of life. Native Hawaiians had to endure the forced imprisonment of their Queen and witness the deterioration and near eradication of their culture and tradition in their own homeland, at the hands of foreigners committed exclusively to propagating Western values and conventions.

While Congress has traditionally treated Native Hawaiians in a manner parallel to American Indians and Alaska Natives, the Federal policy of self-governance and self-determination has not been formally extended to Native Hawaiians. The bill itself does not extend Federal recognition--it authorizes the process for Federal recognition.

The Native Hawaiian Government Reorganization Act of 2007 does three things: (1) It authorizes an office in the Department of the Interior to serve as a liaison between Native Hawaiians and the United States; (2) It forms an interagency coordinating group composed of officials from Federal agencies who currently administer programs and services impacting Native Hawaiians; and (3) It authorizes a process for the reorganization of the Native Hawaiian governing entity for the purposes of a federally recognized government-to-government relationship.

Once the Native Hawaiian governing entity is recognized, the bill establishes an inclusive, democratic negotiations process representing both Native Hawaiians and non-Native Hawaiians. Negotiations between the Native Hawaiian entity and the Federal and State governments may address issues such as the transfer of lands, assets, and natural resources and jurisdiction over such lands, assets, and natural resources, as well as other longstanding issues resulting from the overthrow of the Kingdom of Hawaii. Any transfers of governmental authority or power will require implementing legislation at the State and Federal levels.

The Hawaii congressional delegation has devoted much time and careful consideration into crafting this legislation. When I first started this process in 1999, our congressional delegation created five working groups to assist with the drafting of this legislation. The working groups were composed of individuals from the Native Hawaiian community, the State of Hawaii, Federal Government, Indian country, Members of Congress, and experts in constitutional law. Collectively, more than 100 people worked together on the initial draft of this legislation. The meetings held with the Native Hawaiian community were open to the public and a number of individuals who had differing views attended the meetings and provided their alternative views on the legislation.

In August 2000, the Senate Committee on Indian Affairs and the House Committee on Resources held joint field hearings on the legislation in Hawaii for 5 days. While the bill passed the U.S. House of Representatives in the 106th Congress, the Senate failed to take action. The bill was subsequently considered by the 107th, l08th, and 109th Congresses. In each Congress, the bill has been favorably reported by the Senate Committee on Indian Affairs and its companion measure has been favorably reported by the House Committee on Resources in the 106th through the 108th Congress.

Most recently in the 109th Congress clarifications were made to the bill. I want to inform my colleagues to the fact that this bill is identical to legislative language negotiated between Senator Inouye and myself, and officials from the Department of Justice, Office of Management and Budget, and the White House. The language satisfactorily addresses concerns expressed in July 2005 by the Bush administration regarding the liability of the United States in land claims, the impact of the bill on military readiness, gaming, and civil and criminal jurisdiction in Hawaii.

With respect to liability of the United States as it relates to land claims, as the author of the Apology Resolution, P.L. 103-150, as well as the Native Hawaiian Government Reorganization Act, I have always maintained that this legislation is not intended to serve as a settlement of any claims nor as a cause of action for any claims. The negotiated language makes clear that any grievances regarding historical wrongs committed against Native Hawaiians by the United States or by the State of Hawaii are to be addressed in the negotiations process between the Native Hawaiian governing entity and Federal and State governments.

As a senior member of the Senate Committee on Homeland Security and Governmental Affairs, as well as the incoming Chairman on the Subcommittee on Readiness and Management of the Senate Committee on Armed Services, military readiness for our Armed Forces is of great importance to me. Due to concerns raised by the Department of Defense to the consultation requirements expected to be facilitated by the Office of Native Hawaiian Relations in the Department of the Interior and the Native Hawaiian Interagency Coordinating Group; negotiated language exempts the Department from these consultation requirements. However, these exemptions do not alter nor terminate requirements of the DoD to consult with Native Hawaiians under the Native Graves Protection and Repatriation Act, NAGPRA, National Historic Preservation Act, NHPA, and other existing statutes.

The bill does not authorize gaming by the Native Hawaiian governing entity. Negotiated language clarifies that gaming may not be conducted by Native Hawaiians or the Native Hawaiian governing entity as a matter of

claimed inherent authority or under the authority of any Federal laws or regulations promulgated by the Secretary of the Interior or the National Indian Gaming Commission. The bill also makes clear that the prohibition applies to any efforts to establish gaming by Native Hawaiians and the Native Hawaiian governing entity in Hawaii and in any other State or Territory. This language only applies to efforts to establish gaming operations as a matter of inherent authority as indigenous peoples or under federal laws pertaining to gaming by native peoples.

The bill makes clear that civil and criminal jurisdiction currently held by the Federal and State governments will remain with the Federal and State governments unless otherwise negotiated and implementing legislation is enacted.

I have described the clarifications that have been made so my colleagues know that our negotiations with the administration have been successful. This language has been publicly available since September 2005 and has been widely distributed. Although such clarifications have been made, I am proud to report that the bill remains true to its intent and purpose--to clarify the existing legal and political relationship between Hawaii's indigenous people, Native Hawaiians and the United States.

Along with our efforts to work with the Bush administration, during the past 4 years, we have worked closely with Hawaii's first Republican governor in 40 years, Governor Linda Lingle to enact this legislation. We have also worked closely with the Hawaii State legislature which has passed three resolutions unanimously in support of federal recognition for Native Hawaiians. I am pleased to announce today that I am again joined by members from both sides of the aisle to introduce this important measure. I mention this, to underscore the fact that this is bipartisan legislation.

In addition to its widespread support by both Native Hawaiians and non-Native Hawaiians in Hawaii, in resolutions adopted by the oldest and largest national Indian organization, the National Congress of American Indians, and the largest organization representing the Native people of Alaska, the Alaska Federation of Natives, the members of both groups have consistently expressed their strong support for enactment of a bill to provide for recognition by the United States of a Native Hawaiian governing entity. Organizations such as the American Bar Association, Japanese American Citizen League, and the National Indian Education Association have also passed resolutions in support of federal recognition for Hawaii's indigenous peoples.

Today I provide my colleagues with a framework to understand the need for this legislation by briefly reviewing (1) Hawaii's past, ancient Hawaiian society prior to Western contact, (2) Hawaii's present, the far reaching consequences of the overthrow, and (3) Hawaii's future.

Hawaii was originally settled by Polynesian voyagers arriving as early as 300 A.D, 1200 years before Europe's great explorers Magellan and Columbus. The Hawaiians braved immense distances guided by their extensive knowledge of navigation and understanding of the marine environment. Isolation followed the era of long voyages, enabling Native Hawaiians to develop distinct political, economic, and social structures which were mutually supportive. As stewards of the land and sea, Native Hawaiians were intimately linked to the environment and they developed innovative methods of agriculture, aquaculture, navigation and irrigation.

With an influx of foreigners into Hawaii, Native Hawaiian populations plummeted due to death from common Western diseases. Those that survived witnessed foreign interest and involvement in their government grow until Queen Liliuokalani was forced by American citizens to abdicate her right to the throne. This devastated the Native Hawaiian people, forever tainting the waters of their identity and tattering the very fabric of their society. For some this injustice, this wound has never healed, manifesting itself in a sense of inferiority and hopelessness leaving many Native Hawaiians at the lowest levels of achievement by all social and economic measures.

Mr. President, 14 years ago the United States enacted the Apology Resolution, 103-150, which acknowledged the 100th anniversary of the overthrow of the Kingdom of Hawaii in which the United States offered an apology to Native Hawaiians and declared its policy to support reconciliation efforts. This is a landmark declaration for it recognizes not only are Native Hawaiians the indigenous people of Hawaii, but of the urgent need for the U.S. to actively engage in reconciliation efforts. This acknowledgment played a crucial role in initiating a healing process and although progress has been made, the path ahead is uncertain.

Frustration has led to anger and festered in the hearts of Hawaii's younger generations, with each child that is taught about this period of Hawaiian history, a loss is relived. It is a burden that Native Hawaiians since the overthrow continue to carry, to know that they were violated in their own homeland and their governance was ripped away unjustly. Despite the perceived harmony, it is the generation of my grandchildren that is growing impatient and frustrated with the lack of progress being made. Influenced by a deep sadness and growing intolerance, an active minority within this generation seeks independence from the United States.

It is for this generation that I work to enact this bill so that there is the structured process to deal with these emotional issues. It is important that discussions are held and that there is a framework to guide appropriate action. For Hawaii is the homeland of the Native Hawaiian people.

A lack of action by the U.S. will only incite and fuel us down a path to a divided Hawaii. A Hawaii where lines and boundaries are drawn and unity severed. However, the legislation I introduce today seeks to build upon the foundation of reconciliation. It provides a structured process to bring together the people of Hawaii, along a path of healing to a Hawaii where its indigenous people are respected and culture is embraced.

Respecting the rights of America's first people--American Indians, Alaska Natives, and Native Hawaiians is not un-American. Through enactment of this legislation, we have the opportunity to demonstrate that our country does not just preach its ideas, but lives according to its founding principles. That the United States will admit when it has trespassed against a people and remain resolute to make amends. We demonstrate our character to ourselves and to the world by respecting the rights of our country's indigenous people. As it has for America's other indigenous peoples, I believe the United States must fulfill its responsibility to Native Hawaiians.

I am proud of the fact that this bill respects the rights of Hawaii's indigenous peoples through a process that is consistent with Federal law, and it provides the structured process for the people of Hawaii to address the longstanding issues which have plagued both Native Hawaiians and non-Native Hawaiians since the overthrow of the Kingdom of Hawaii. We have an established record of the United States' commitment to the reconciliation with Native Hawaiians. This legislation is another step building upon that foundation and honoring that commitment.

I ask my colleagues to join me in enacting this legislation which is of great importance to all the people of Hawaii.

Mr. President, I ask unanimous consent that the text of this measure be printed in the Record.

Mr. President, I rise today along with my distinguished colleagues, Senator Wyden, Senator Bunning, Senator Inouye, and Senator Durbin, to introduce the Paleontological Resources Preservation Act in order to protect and preserve the Nation's important fossil record for the benefit of our citizens. Vertebrate fossils are rare and important natural resources that have become increasingly endangered due to an increase in the illegal collection of fossil specimens for commercial sale. However, at this time there is no unified policy regarding the treatment of fossils by Federal land management agencies which would help protect and conserve fossil specimens. Consequently, we risk the deterioration or loss of these valuable scientific resources. This Act will correct that omission by providing uniformity to the patchwork of statutes and regulations that currently exist. By creating a comprehensive national policy for preserving and managing paleontological resources found on Federal land, this Act will also be instrumental in curtailing and preventing future illegal trade thereby ensuring that many generations to come will have access to these invaluable records of our past. I would like to emphasize that this bill covers only paleontological remains on Federal lands and in no way affects archaeological or cultural resources under the Archaeological Resources Protection Act of 1979 or the Native American Graves Protection and Rehabilitation Act.

I would also mention that this bill is exactly the same bill that I introduced

in the 109th Congress. This bill was heard and marked up by the Senate Energy and Natural Resources Committee, and was passed by the Senate.

As a senior member of the Senate Energy and Natural Resources Committee and Chair of the Subcommittee on National Parks, I am very concerned about the preservation of fossils as records of earth's past upheavals and struggles. While I recognize the value of amateur collecting--and casual collecting--of fossils is protected in this bill--fossil theft has become an increasing problem. New fossil fields and insights into the earth's past are discovered nearly every month. Paleontological resources can be sold on the market for a hefty price. For example, the complete skeleton of a T-Rex was sold for $8.6 million at auction to the Field Museum of Chicago. Consequently, they are being stolen from public lands without regard to science and education. The protections I offer in this Act are not new. Federal and management agencies have individual regulations prohibiting theft of government property. However, Congress has not provided a clear statute stating the value of paleontological resources to our Nation, as we have for archeological resources. We need to work together to make sure that we fulfill our responsibility as stewards of public lands, and as protectors of our Nation's natural resources.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.